FDA.reportPublic FDA data

Denovo Dental Crown Contouring Johnson #114

Primary DI
00810059291614
Brand
Denovo Dental Crown Contouring Johnson #114
Company
Denovo Dental, Inc.
Model
800-114
Device description
Denovo Dental Crown Contouring Johnson #114
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810059291614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810059291614008100592916148100592916140810059291614

GMDN Terms#

Term, Definition table
TermDefinition
Dental precision attachment fitting/adjustment toolA manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183498179
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810059291584Denovo Dental Crown Removing Plier800-015 2023-06-30
00810059291256Dental Matrix System Wedges180-411 2023-06-30
00810059291263Dental Matrix System Wedges180-4132023-06-30
00810059290006Denovo general purpose dental molar band160-1462023-06-30
00810059290013Denovo general purpose dental molar band160-147 2023-06-30
00810059290020Denovo general purpose dental molar band160-148 2023-06-30
00810059290037Denovo general purpose dental molar band160-1492023-06-30
00810059290044Denovo general purpose dental molar band160-150 2023-06-30
00810059290051Denovo general purpose dental molar band160-151 2023-06-30
00810059290068Denovo general purpose dental molar band160-152 2023-06-30
00810059290075Denovo general purpose dental molar band160-153 2023-06-30
00810059290082Denovo general purpose dental molar band160-154 2023-06-30
00810059290099Denovo general purpose dental molar band160-155 2023-06-30
00810059290105Denovo general purpose dental molar band160-156 2023-06-30
00810059290112Denovo general purpose dental molar band160-157 2023-06-30
00810059290129Denovo general purpose dental molar band160-158 2023-06-30
00810059290143Denovo general purpose dental molar band160-160 2023-06-30
00810059290150Denovo general purpose dental molar band160-161 2023-06-30
00810059290167Denovo general purpose dental molar band160-162 2023-06-30
00810059290174Denovo general purpose dental molar band160-163 2023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001170Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001354Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001460Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001477Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001484Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001491Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001507Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001514Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001521Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001538Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22