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KROMALGIN Piu 300x18g

FDA UDI

Class II (US FDA UDI)

by Vannini Dental Industry Srl

Identity

Trade Name
KROMALGIN Piu 300x18g FDA UDI
Generic Name
Alginate dental impression material FDA UDI
Device Name
Alginate for dental impressions FDA UDI
Model / Reference
002003 FDA UDI
Description
Alginate for dental impressions FDA UDI

Identifiers

Catalog Number
002003 FDA UDI
Primary DI / UDI-DI
00803371256102 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Total Volume — 27280 Milliliter FDA UDI

KROMALGIN Piu 300x18g by Vannini Dental Industry Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K963609 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vannini Dental Industry Srl

Sources (1)

  • FDA UDI 25ff8c8e-e8ef-4b1c-b507-304069dd1b9e 39 fields · synced May 30, 2026