Imprint™ 4 Penta™ Heavy

FDA UDI

Class I (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: Imprint™ 4 Penta™ Heavy FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: 3M™ ESPE™ Imprint™ 4 Penta™ Heavy Trial Kit, 71497 FDA UDI
Model / Reference: 71497 FDA UDI
Description: 3M™ ESPE™ Imprint™ 4 Penta™ Heavy Trial Kit, 71497 FDA UDI

Identifiers

Catalog Number: 71497 FDA UDI
Primary DI / UDI-DI: J001702011415230 FDA UDI
FDA Product Code: EID FDA UDI
ELW FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
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: Silicone dental impression material Dental material injection cannula, single-use Dental material mixing nozzle

Imprint™ 4 Penta™ Heavy by 3M Deutschland GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: 3M Deutschland GmbH

Sources (1)

FDA UDI 77d3f9e3-50fa-4925-a543-6ce226f6221b 35 fields · synced May 30, 2026