FDA.reportPublic FDA data

Anterior master mix

Primary DI
E29969990
Brand
Anterior master mix
Company
Polydentia SA
Model
6999
Published
2022-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E29969990PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481461598
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E2995300200stop card5300205300202025-11-24
E2995300300stop card5300305300302025-11-24
E2995300400stop card5300405300402025-11-24
E2995300500stop card5300505300502025-11-24
E2995300600stop card5300605300602025-11-24
E2995300700stop card5300705300702025-11-24
E2995300800stop card5300805300802025-11-24
E29954050Cotton Roll Holder540554052025-11-24
E2995300209stop card5300205300202025-11-24
E2995300309stop card5300305300302025-11-24
E2995300409stop card5300405300402025-11-24
E2995300509stop card5300505300502025-11-24
E2995300609stop card5300605300602025-11-24
E2995300709stop card5300705300702025-11-24
E2995300809stop card5300805300802025-11-24
E29954059Cotton Roll Holder540554052025-11-24
E29912010Unica proximal120112012025-10-31
E29912019Unica proximal120112012025-10-31
E29968910myRing Prime689168912025-06-16
E29950020wood wedges500250022025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21