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Anew Implant System

FDA UDI

Class II (US FDA UDI)

by Dentatus AB

Identity

Trade Name
Anew Implant System FDA UDI
Generic Name
Transgingival implant FDA UDI
Device Name
Dentatus Anew Implant FDA UDI
Model / Reference
ST-24S FDA UDI
Description
Dentatus Anew Implant FDA UDI

Identifiers

Primary DI / UDI-DI
07350081495138 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Transgingival implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

Yes

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: Transgingival implant

Anew Implant System by Dentatus AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transgingival implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentatus AB

Sources (1)

  • FDA UDI 1dc6ec0c-241c-4ea2-8987-f00ff3108fd8 34 fields · synced Jun 8, 2026