FDA.report

Digital Analogue RP

Primary DI
07901059074697
Brand
Digital Analogue RP
Company
RP - CONEXOES RESTAURADORAS LTDA
Model
Digital Analogue
Catalog number
D100440
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07901059074697PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
898813604
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07901059074338Digital Analogue NPDigital AnalogueD1004002026-02-09
07901059074345Digital Analogue RPDigital AnalogueD1004012026-02-09
07901059074352Digital Analogue Digital AnalogueD1004022026-02-09
07901059074369Digital Analogue NPDigital AnalogueD1004042026-02-09
07901059074376Digital Analogue RP Digital AnalogueD1004052026-02-09
07901059074383Digital Analogue WP Digital AnalogueD1004062026-02-09
07901059074390Digital Analogue RN Digital AnalogueD1004072026-02-09
07901059074406Digital Analogue WNDigital AnalogueD1004082026-02-09
07901059074413Digital Analogue NCDigital AnalogueD1004092026-02-09
07901059074420Digital Analogue RC Digital AnalogueD1004102026-02-09
07901059074437Digital Analogue SRADigital Analogue2026-02-09
07901059074444Digital Analogue RB/WBDigital AnalogueD1004122026-02-09
07901059074451Digital Analogue NPDigital AnalogueD1004142026-02-09
07901059074468Digital Analogue SP Digital AnalogueD1004152026-02-09
07901059074475Digital Analogue V3 SPDigital AnalogueD1004172026-02-09
07901059074482Digital AnalogueDigital AnalogueD1004192026-02-09
07901059074499Digital AnalogueDigital AnalogueD1004202026-02-09
07901059074505Digital Analogue EV/3.0Digital AnalogueD1004212026-02-09
07901059074512Digital Analogue EV/3.6Digital AnalogueD1004222026-02-09
07901059074529Digital Analogue EV/4.2Digital AnalogueD1004232026-02-09

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