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Osstell SmartPeg Type 41

FDA UDI

Class I (US FDA UDI)

by Osstell AB

Identity

Trade Name
Osstell SmartPeg Type 41 FDA UDI
Generic Name
Dental implant stability resonance frequency analysis peg FDA UDI
Device Name
ISQ Measurement Peg FDA UDI
Model / Reference
Osstell SmartPeg Type 41 FDA UDI
Description
ISQ Measurement Peg FDA UDI

Identifiers

Catalog Number
100463 FDA UDI
Primary DI / UDI-DI
09010522001516 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental implant stability resonance frequency analysis peg FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental implant stability resonance frequency analysis peg

Osstell SmartPeg Type 41 by Osstell AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant stability resonance frequency analysis peg.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osstell AB

Sources (1)

  • FDA UDI 4e57c722-2253-453f-b2e0-2a343abd56cf 34 fields · synced Jun 8, 2026