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Fixer

FDA UDI

Class II (US FDA UDI)

by S.I.N. - Sistema DE Implante Nacional S.A.

Identity

Trade Name
Fixer FDA UDI
Generic Name
Dental implant holding endpiece, reusable FDA UDI
Device Name
IMPLANT FIXER MICRO MINI SHORT FDA UDI
Model / Reference
MI 3403 FDA UDI
Description
IMPLANT FIXER MICRO MINI SHORT FDA UDI

Identifiers

Catalog Number
MI 3403 FDA UDI
Primary DI / UDI-DI
07899995201034 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant holding endpiece, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental implant holding endpiece, reusable

Fixer by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant holding endpiece, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.I.N. - Sistema DE Implante Nacional S.A.

Sources (1)

  • FDA UDI fe842cd7-8867-4cfa-a26e-30f055cf3dd1 34 fields · synced Jun 6, 2026