Beyond

FDA UDI

Class II (US FDA UDI)

by Ada Products Co, Inc

Identity

Trade Name: Beyond FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: Temporary Cement, 5ml Syringe FDA UDI
Model / Reference: 40323 FDA UDI
Description: Temporary Cement, 5ml Syringe FDA UDI

Identifiers

Primary DI / UDI-DI: 00813277020219 FDA UDI
510(k) Number: K960938 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge resin

Beyond by Ada Products Co, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary dental crown/bridge resin.

Alpha-Crown® — Dental Technologies, Inc. · Class II
JET TOOTH SHADE POWDER — Lang Dental Manufacturing Company, Inc. · Class II
UNIFAST™ — Gc America Inc. · Class II
MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
tempofit premium BL — DETAX GmbH · Class II
YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · Class II

Cleared under the same submission

K960938 also covers:

Beyond — ADA PRODUCTS CO, INC

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: Ada Products Co, Inc

Sources (1)

FDA UDI 5a8a468a-c792-4ba2-8557-1e61d6bc47b9 36 fields · synced Jun 8, 2026