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Aeton Medical

FDA UDI

Class II (US FDA UDI)

by Aeton Medical

Identity

Trade Name
Aeton Medical FDA UDI
Generic Name
Dental implant kit FDA UDI
Device Name
ST Abutment Set - 6.5mm X 5.5mm FDA UDI
Model / Reference
AMSTAS655 FDA UDI
Description
ST Abutment Set - 6.5mm X 5.5mm FDA UDI

Identifiers

Primary DI / UDI-DI
00810063330774 FDA UDI
FDA Product Code
DZE FDA UDI
NHA FDA UDI
GMDN Term
Dental implant kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant kit

Aeton Medical by Aeton Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aeton Medical

Sources (1)

  • FDA UDI 0ec2023b-fc23-47ef-82e1-8d20d36054c4 33 fields · synced Jun 6, 2026