Dimension™ Garant™ L

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name: Dimension™ Garant™ L FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: 3M™ ESPE™ Dimension™ Garant™ L VPS Impression Material Refill, 36515 FDA UDI
Model / Reference: 36515 FDA UDI
Description: 3M™ ESPE™ Dimension™ Garant™ L VPS Impression Material Refill, 36515 FDA UDI

Identifiers

Catalog Number: 36515 FDA UDI
Primary DI / UDI-DI: J001702011127890 FDA UDI
FDA Product Code: ELW FDA UDI
EID FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
872.4565 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 mixing nozzle

Dimension™ Garant™ L by 3M Deutschland GmbH — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: 3M Deutschland GmbH

Sources (1)

FDA UDI 188435a0-728d-47c1-913a-5fd3829e0e82 35 fields · synced May 30, 2026