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Neoss SmartPeg Mount

FDA UDI

Class I (US FDA UDI)

by Osstell AB

Identity

Trade Name
Neoss SmartPeg Mount FDA UDI
Generic Name
Dental implant stability resonance frequency analysis unit FDA UDI
Device Name
SmartPeg Mount FDA UDI
Model / Reference
Neoss SmartPeg Mount FDA UDI
Description
SmartPeg Mount FDA UDI

Identifiers

Catalog Number
91075 FDA UDI
Primary DI / UDI-DI
09010522002469 FDA UDI
510(k) Number
K181888 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental implant stability resonance frequency analysis unit 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant stability resonance frequency analysis unit

Neoss SmartPeg Mount 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 unit.

Cleared under the same submission

K181888 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osstell AB

Sources (1)

  • FDA UDI eb91c67a-b486-48b9-a9ad-1156d0dae526 35 fields · synced Jun 8, 2026