UltraSil Putty 1000

FDA UDI

Class II (US FDA UDI)

by Dsi Dental Solutions, Ltd.

Identity

Trade Name: UltraSil Putty 1000 FDA UDI
Generic Name: Composite dental impression material FDA UDI
Model / Reference: US-P1000 FDA UDI

Identifiers

Primary DI / UDI-DI: D95600USP1000 FDA UDI
510(k) Number: K222741 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Composite 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

Category: Composite dental impression material

UltraSil Putty 1000 by Dsi Dental Solutions, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K222741 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: Dsi Dental Solutions, Ltd.

Sources (1)

FDA UDI 97480b2f-8d2e-4b00-8658-c1ca2be50dd9 33 fields · synced May 30, 2026