Materials
PFM ALLOYS
K842551
Base Alloy (NP) – MEALLOY
Device Classification Name : Alloy, Metal, Base
FDA Establishment name and number – DENTSPLY CAULK 2515379
Device Name: BASE METAL ALLOY
510K # K842551 / Regulation Number: 872.3710 / Code: EJH
K020253
Base Alloy (NP) – 4 ALL
Device Classification Name : Alloy, Metal, Base
FDA Establishment name and number – IVOCLAR VIVADENT, INC. 1316092
Device Name: 4 ALL (DW286A)
510K # K842551 / Regulation Number: 872.3710 / Code: EJH
K032136
Base Alloy (NP) – Ni Free WIROBOND C
Device Classification Name : Alloy, Metal, Base
FDA Establishment name and number – BEGO MEDICAL AG 3005301332
Device Name: BASE METAL ALLOY
510K # K032136 / Regulation Number: 872.3710 / Code: EJH
K892811
Nobel Alloy (SP) ARGELITE 54B
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGELITE 54B
510 K # K892811 / Regulation Number: 872.3060 / Code: EJT
K940281
High Noble White Ceramic (HNW-51SF): ARGEDENT EURO
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGEDENT 51SF
510K # K940281 / Regulation Number: 872.3060 / Code: EJT
K891989
High Noble White Ceramic (HNW-52): ARGEDENT 52
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGEDENT 52 (DENTAL ALLOY)
510K # K891989 / Regulation Number: 872.3060 / Code: EJT
K892234
High Noble Yellow Ceramic (HNY-75): ARGEDENT 75
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGEDENT 75
510K # K892234 / Regulation Number: 872.3060 / Code: EJT
K892708
High Noble Yellow Ceramic (HNY-86): ARGEDENT 86
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGEDENT Y-86 DENTAL ALLOY
510K # K892708 / Regulation Number: 872.3060 / Code: EJT
K932243
High Noble Yellow Captek (Captek): CAPTEK
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – PRECIOUS CHEMICALS LTD. # 8030119
Device Name – GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOL
510K # K932243 / Regulation Number: 872.3060 / Code: EJT
FULL CAST CROWN ALLOYS
K893567
High Noble Yellow Full Cast IV (HNY-52 IV): ARGENCO 52
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGENCO 52″ TYPE IV DENTAL GOLD ALLOY
510K # K893567 / Regulation Number: 872.3060 / Code: EJT
K893383
High Noble Yellow Full Cast III (HNY-75 III): ARGEDENT 75
Device Classification Name : Alloy, Gold-based Noble Metal
FDA Establishment name and number – THE ARGEN CORPORATION # 2433919
Device Name – ARGENCO 75 TYPE III DENTAL GOLD ALLOY
510K # K893383 / Regulation Number: 872.3060 / Code: EJT
RPD ALLOYS
K030632
Base Alloy (RPD) – PD CASTA-H
Device Classification Name : Alloy, Metal, Base
FDA Establishment name and number – MOUNTAIN MEDICO, INC. # 2086103
Device Name – PD CASTA-H
510K # K030632 / Regulation Number: 872.3710 / Code: EJH
K970205
Base Alloy (RPD) – VITALLIUM 2000
Device Classification Name : Alloy, Metal, Base
FDA Establishment name and number – DENTSPLY CAULK # 2515379
Device Name – VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY
510K # K970205 / Regulation Number: 872.3710 / Code: EJH
CERAMIC COMPONENTS
K071848
Porcelain: Ivoclar Vivadent IPS Inline
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – Ivoclar Vivadent, AG 8010208
Device Name: IPS INLINE POM SYSTEM
510K # K071848 / Regulation Number 872.6660 / Code: EIH
K830553
Porcelain: Ceramco 3
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – DENTSPLY PROSTHETICS 2248025
Device Name: DENTAL PORCELAIN POWDER
510K #K830553 / Regulation Number 872.6660 / Code: EIH
K051705
Porcelain: Ivoclar Vivadent – IPS E.MAX ZIRCAD
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – Ivoclar Vivadent, AG 8010208
Device Name: IPS E.MAX CAD/IPS E.MAX ZIRCAD
510K # K051705 / Regulation Number 872.6660 / Code: EIH
K982616
Porcelain: Ivoclar Vivadent – IPS EMPRESS ERIS
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – IVOCLAR VIVADENT AG 8010208
Device Name: IPS EMPRESS 2
510K # K982616 / Regulation Number 872.6660 / Code: EIH
K913372
Porcelain: Ivoclar Vivadent – IPS EMPRESS
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – IVOCLAR VIVADENT AG 8010208
Device Name: IPS EMPRESS
510K # K913372 / Regulation Number 872.6660 / Code: EIH
K921623
Porcelain: Ivoclar Vivadent – VITA ALPHA
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – VIDENT 2082832
Device Name: VITADUR ALPHA PORCELAIN
510K # K913372 / Regulation Number 872.6660 / Code: EIH
K031968
Porcelain: NORITAKE – CERABIEN ZR
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – NORITAKE KIZAI CO., LTD. 9614705
Device Name: CERABIEN ZR
510K # K031968 / Regulation Number 872.6660 / Code: EIH
K022796
Porcelain: DEGUSSA – CERCON CERAM
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – DEGUDENT GMBH 9681199
Device Name: CERCON CERAM S PORCELAIN
510K # K011333 / Regulation Number 872.6660 / Code: EIH
K050144
Porcelain: PRISMATIK CERAMIC
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – PRISMATIK DENTALCRAFT, INC. 3005477956
Device Name: PRISMATIK CERAMIC
510K # K050144/ Regulation Number 872.6660 / Code: EIH
K072569
Zirconia Block: ZR CAD-CAM BLOCK
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – METOXIT AG / 3003851124
Device Name: METOXIT CAM-BLANKS
510K # K072569 / Regulation Number 872.6660 / Code: EIH
K052033
Porcelain: Shofu Vintage ZR Porcelain
Device Classification Name : Powder, Porcelain
FDA Establishment name and number – Shofu Dental Corp. 2916735
Device Name: VINTAGE ZR
510K # K052033 / Regulation Number 872.6660 / Code: EIH
ACRYLIC & TEETH
K972573
Acrylic: DENTSPLY – DENTAL RESIN
Device Classification Name : Resin, Denture, Relining, Repairing, Rebasing
FDA Establishment name and number – DENTSPLY CAULK 2515379
Device Name: LIQCRYLIC PRO DENTAL RESIN
510K # K972573 / Regulation Number 872.3760 / Code: EBI
K992956
Acrylic: DENTSPLY – LUCITONE FLEXIBEL DENTAL RESIN
Device Classification Name : Resin, Denture, Relining, Repairing, Rebasing
FDA Establishment name and number – DENTSPLY CAULK 2515379
Device Name: LUCITONE FRS FLEXIBEL DENTAL RESIN
510K # K992956 / Regulation Number 872.3760 / Code: EBI
K053060
Thermoplastic: TCS FLEXIBEL DENTAL RESIN
Device Classification Name : Resin, Denture, Relining, Repairing, Rebasing
FDA Establishment name and number – THERMOPLASTIC COMFORT SYSTEMS, INC. 2032807
Device Name: TCS UNBREAKABLE
510K # K053060 / Regulation Number 872.3760 / Code: EBI
K792245
Denture Teeth: Dentsply
Device Classification Name : Denture, Plastic, Teeth
FDA Establishment name and number – DENTSPLY CAULK 2515379
Device Name: TEETH, DENTURE, PLASTIC
510K # K792245 / Regulation Number 872.3590 / Code: ELM
K011560
Acrylic: DENTSPLY – LUCITONE 199
Device Classification Name : Resin, Denture, Relining, Repairing, Rebasing
FDA Establishment name and number – DENTSPLY CAULK 2515379
Device Name:
510K # K011560 / Regulation Number 872.3760 / Code: EBI