A-dec

FDA UDI

Class II (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name: A-dec FDA UDI
Generic Name: Intraoral camera FDA UDI
Device Name: KaVo DIAGNO cam Vision Full HD camera Kit FDA UDI
Model / Reference: 54.1041.00 FDA UDI
Description: KaVo DIAGNO cam Vision Full HD camera Kit FDA UDI

Identifiers

Catalog Number: 54.1041.00 FDA UDI
Primary DI / UDI-DI: 10194665007928 FDA UDI
510(k) Number: K182712 FDA UDI
FDA Product Code: NTK FDA UDI
GMDN Term: Intraoral camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1745 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraoral camera

A-dec by A-Dec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PXL — Digital Doc LLC · Class I
Opti plus HD — Dentall Corporation · Class I
LED IC100 — Dentall Corporation · Class I
APOZA — APOZA ENTERPRISE CO., LTD. · Class I

Cleared under the same submission

K182712 also covers:

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: A-Dec, Inc.

Sources (1)

FDA UDI 24693a5b-6349-4663-93d0-35da71491763 35 fields · synced May 30, 2026