CLIPALGIN 18 g

FDA UDI

Class II (US FDA UDI)

by Vannini Dental Industry Srl

Identity

Trade Name: CLIPALGIN 18 g FDA UDI
Generic Name: Alginate dental impression material FDA UDI
Device Name: Alginate for dental impressions FDA UDI
Model / Reference: 002025 FDA UDI
Description: Alginate for dental impressions FDA UDI

Identifiers

Catalog Number: 002025 FDA UDI
Primary DI / UDI-DI: 08033712560250 FDA UDI
510(k) Number: K963609 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Alginate dental impression material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Total Volume — 27280 Milliliter FDA UDI

Category: Alginate dental impression material

CLIPALGIN 18 g by Vannini Dental Industry Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alginate dental impression material.

Bosworth Supergel — Harry J. Bosworth Co. · Class II
Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material — Dentsply International · Class II
Orthoquest — Young Innovations, Inc. · Class II
MDC Dental — MDC DENTAL · Class II
KROMOPAN — Lascod Spa · Class II
Allgilloid Plus™ Chromatic Mint Alginate — ORTHO SPECIALTIES · Class II
Orthoquest — Young Innovations, Inc. · Class II
Powder scoop + Water measure Neutral — Cavex Holland B.V. · Class II

Cleared under the same submission

K963609 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: Vannini Dental Industry Srl

Sources (1)

FDA UDI 8ee3c474-167f-47e4-b047-d3aab32a6c03 38 fields · synced May 30, 2026