Insti-Dam®

FDA UDI

Class I (US FDA UDI)

by Zirc Dental Products, Inc.

Identity

Trade Name: Insti-Dam® FDA UDI
Generic Name: Rubber dam, non-latex FDA UDI
Device Name: Insti-Dam Relaxed Fit 5pk for Isolation Power Pack FDA UDI
Model / Reference: 50Z457-360 FDA UDI
Description: Insti-Dam Relaxed Fit 5pk for Isolation Power Pack FDA UDI

Identifiers

Primary DI / UDI-DI: 10840161307030 FDA UDI
FDA Product Code: EIE FDA UDI
GMDN Term: Rubber dam, non-latex FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6300 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 121 Millimeter FDA UDI
Width — 124 Millimeter FDA UDI
Height — 70 Millimeter FDA UDI

Category: Rubber dam, non-latex

Insti-Dam® by Zirc Dental Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Rubber dam, non-latex.

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Gingival Barrier — ULTRADENT PRODUCTS, INC. · Class I
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OpalDam — ULTRADENT PRODUCTS, INC. · Class I
True™ Dental Dam Latex Free 6x6 — Den-Mat Holdings, LLC · 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 I	Pending data

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Manufacturer

Manufacturer: Zirc Dental Products, Inc.

Sources (1)

FDA UDI be58376d-01e5-4616-b1ef-024c2128505f 34 fields · synced May 30, 2026