A-dec

FDA UDI

Class I (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name: A-dec FDA UDI
Generic Name: Dental delivery system FDA UDI
Device Name: A-dec 336pro TRAD Radius Delivery System FDA UDI
Model / Reference: 336pro FDA UDI
Description: A-dec 336pro TRAD Radius Delivery System FDA UDI

Identifiers

Catalog Number: 336pro FDA UDI
Primary DI / UDI-DI: 10194665005894 FDA UDI
510(k) Number: K213932 FDA UDI
FDA Product Code: EIA FDA UDI
GMDN Term: Dental delivery system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental delivery system

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

Similar devices

Also classified as Dental delivery system.

Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
V8 TOUCH — VITALI S.R.L. · Class IIa
Forest — Ls Enterprises, Inc. · Class I
Forest — Ls Enterprises, Inc. · Class I
TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
Forest — Ls Enterprises, Inc. · Class I
A5 SINGLE CART — CEFLA s.c. · Class IIa
Forest — Ls Enterprises, Inc. · Class I

Cleared under the same submission

K213932 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 I	Pending data

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Manufacturer

Manufacturer: A-Dec, Inc.

Sources (1)

FDA UDI 6596ca17-39bf-4009-b023-ed2462c06016 35 fields · synced May 30, 2026