FDA.report

STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORM

Primary DI
08435389828945
Brand
STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORM
Company
BIOTECHNOLOGY INSTITUTE SL
Model
K3CG
Published
2025-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OFYDental Implant Surgical Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389828945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389828945084353898289458435389828945

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
461665312
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

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08435389828952EXTRACTOR FOR IMPLANTS 8EXIM82026-01-30
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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08435451660466KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660473KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660480KLOCKNERSOADCO, S.L.OFY2025-02-14
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04260516874885SIC invent Dental Implant SystemsSIC invent AGOFY2024-10-18
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