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Universal Mixing Tip

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name
UNIVERSAL MIXING TIP FDA UDI
Generic Name
Silicone dental impression material FDA UDI
Model / Reference
60021853 FDA UDI

Identifiers

Catalog Number
60021853 FDA UDI
Primary DI / UDI-DI
J006600218530 FDA UDI
510(k) Number
K912485 FDA UDI
FDA Product Code
ELW FDA UDI
GMDN Term
Silicone 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Universal Mixing Tip by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K912485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coltène/Whaledent AG

Sources (1)

  • FDA UDI ff5e0da2-e1c5-4315-a39f-f316b12b600b 36 fields · synced Jun 6, 2026