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A-Oss®

FDA UDI

Class II (US FDA UDI)

by Hiossen Inc.

Identity

Trade Name
A-Oss® FDA UDI
Generic Name
Dental bone matrix implant, animal-derived FDA UDI
Model / Reference
AOSN050SV FDA UDI

Identifiers

Primary DI / UDI-DI
00814913024233 FDA UDI
510(k) Number
K151542 FDA UDI
FDA Product Code
NPM FDA UDI
GMDN Term
Dental bone matrix implant, animal-derived FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

A-Oss® by Hiossen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151542 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hiossen Inc.

Sources (1)

  • FDA UDI ba23c038-660a-45bf-b0e5-f45e7c5d1243 34 fields · synced Jun 8, 2026