FDA.report

ABUTMENT UNIT INTERNA 3.0 2.5 MM

Primary DI
08435389829164
Brand
ABUTMENT UNIT INTERNA 3.0 2.5 MM
Company
BIOTECHNOLOGY INSTITUTE SL
Model
INTMIUP325
Published
2025-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389829164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389829164084353898291648435389829164

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods

Method

Regulatory Flags

DUNS number
461665312
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08435389828969EXTRACTOR FOR IMPLANTS 9EXIM92026-01-30
08435389829027SHORT DRILL; Ø2,2 MMF22CS2026-01-30
08435389829034SHORT DRILL; Ø2,3 MMF23CS2026-01-30
08435389829041SHORT DRILL; Ø2,4 MMF24CS2026-01-30
08435389829058SHORT DRILL; Ø2,0 MMF20CS2026-01-30
08435389829096FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 FCFA55C2026-01-30
08435389830061EXTRA SHORT INITIAL DRILLFIXS2026-01-30
08435389830078EXTRA SHORT DRILL; Ø1,8 MMF18XS2026-01-30
08435389830085EXTRA SHORT DRILL; Ø1,8/2,5 MMF1825XS2026-01-30
08435389830092EXTRA SHORT DRILL; Ø2,5 MMF25XS2026-01-30
08435389830108EXTRA SHORT DRILL; Ø2,8 MMF28XS2026-01-30
08435389830115EXTRA SHORT DRILL; Ø3 MMF30XS2026-01-30
08435389830269HEATING OVEN H-PLUSBTI H-PLUS2026-01-30
08435389830276DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-01-30
08435389830320SHORT DRILL; Ø1.5 MMF15CS2026-01-30
08435389829706EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORMISMIPAX2026-01-29
08435389829713EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORMISMIUPAX2026-01-29
08435389829843MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MMINTMIP335452026-01-29
08435389829850MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MMINTMIP3452026-01-29

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