Aeton Medical

FDA UDI

Class II (US FDA UDI)

by Aeton Medical

Identity

Trade Name: Aeton Medical FDA UDI
Generic Name: Dental implant abutment impression cap FDA UDI
Device Name: Impression Cap - 6.5mm FDA UDI
Model / Reference: STIC65 FDA UDI
Description: Impression Cap - 6.5mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00810063330200 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
GMDN Term: Dental implant abutment impression cap 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant abutment impression cap

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

Similar devices

Also classified as Dental implant abutment impression cap.

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OKTAGON® — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
Zibone — COHO BIOMEDICAL TECHNOLOGY CO., LTD. · Class I
Transfer Abutment — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
TSI/ERI Indexing Impression Coping — Oco Biomedical · Class I
i-Clean Excellent Solid Impression Cap — DENTIS CO. , LTD · Class I
TSI/ERI Indexing Impression Coping — Oco Biomedical · Class I
TSI IMPRESSION COPING SPLINE — Oco Biomedical · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Aeton Medical

Sources (1)

FDA UDI 64d82628-276e-4746-a236-04f2fa563f6f 33 fields · synced Jun 8, 2026