FDA.reportPublic FDA data

Digital Analogue WN

Primary DI
07901059074406
Brand
Digital Analogue WN
Company
RP - CONEXOES RESTAURADORAS LTDA
Model
Digital Analogue
Catalog number
D100408
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07901059074406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07901059074406079010590744067901059074406

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
898813604
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
079010590848701.3mm Square manual wrench - ShortInstrumental13QMWS2026-04-24
079010590848871.3mm Square manual wrench - IntermediateInstrumental13QMWI2026-04-24
079010590848941.3mm Square manual wrench - LongInstrumental13QMWL2026-04-24
079010590849001.3mm Square manual wrench – Extra LongInstrumental13QMWEL2026-04-24
07901059084917Manual Wrench for Multi-Unit - ShortInstrumentalMWFMS2026-04-24
07901059084924Manual Wrench for Multi-Unit - IntermediateInstrumentalMWFMI2026-04-24
07901059084931Manual Wrench for Multi-Unit - LongInstrumentalMWFML2026-04-24
07901059084948Torx Manual Wrench - ShortInstrumentalTXMWS2026-04-24
07901059084955Torx Manual Wrench - IntermediateInstrumentalTXMWI2026-04-24
07901059084962Torx Manual Wrench - LongInstrumentalTXMWL2026-04-24
07901059084979Torx Manual Wrench – Extra LongInstrumentalTXMWEL2026-04-24
07901059084986Angle Manual Wrench - ShortInstrumentalAMWS2026-04-24
07901059084993Angle Manual Wrench - IntermediateInstrumentalAMWI2026-04-24
07901059085006Angle Manual Wrench – LongInstrumentalAMWL2026-04-24
07901059085013Unigrip Manual Wrench - ShortInstrumentalUMWS2026-04-24
07901059085020Unigrip Manual Wrench - IntermediateInstrumentalUMWI2026-04-24
07901059085037Unigrip Manual Wrench – LongInstrumentalUMWL2026-04-24
07901059085044Unigrip Manual Wrench – Extra LongInstrumentalUMWEL2026-04-24
079010590850511.28mm Hexagonal Manual Wrench - ShortInstrumental128HMWS2026-04-24
079010590850681.28mm Hexagonal Manual Wrench - IntermediateInstrumental128HMWI2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08