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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 suprastructure, temporary, custom-made FDA UDI
Device Name
Burn Out Coping - 6.5mm x 8.9mm, Flat FDA UDI
Model / Reference
STFBC65 FDA UDI
Description
Burn Out Coping - 6.5mm x 8.9mm, Flat FDA UDI

Identifiers

Primary DI / UDI-DI
00810063330224 FDA UDI
FDA Product Code
DZE FDA UDI
NHA FDA UDI
GMDN Term
Dental implant suprastructure, temporary, custom-made 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 suprastructure, temporary, custom-made

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

Similar devices

Also classified as Dental implant suprastructure, temporary, custom-made.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aeton Medical

Sources (1)

  • FDA UDI b13dfa6b-6b0f-4d01-8f92-4eb5065d43fc 33 fields · synced May 30, 2026