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Rocatec™ Plus

FDA UDI

Class II (US FDA UDI)

by 3M Deutschland GmbH

Identity

Trade Name
Rocatec™ Plus FDA UDI
Generic Name
Dental composite resin kit FDA UDI
Device Name
3M™ ESPE™ Rocatec™ Plus Micro-Abrasion Bonding/Coating For Metal, Ceramic And Plastic Materials Refill, 68376 FDA UDI
Model / Reference
68376 FDA UDI
Description
3M™ ESPE™ Rocatec™ Plus Micro-Abrasion Bonding/Coating For Metal, Ceramic And Plastic Materials Refill, 68376 FDA UDI

Identifiers

Catalog Number
68376 FDA UDI
Primary DI / UDI-DI
J001702011357720 FDA UDI
FDA Product Code
EJH FDA UDI
GMDN Term
Dental composite resin kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3710 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental composite resin kit

Rocatec™ Plus by 3M Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3M Deutschland GmbH

Sources (1)

  • FDA UDI 373cdfdb-0ced-45a6-90b5-5af964a1eb24 35 fields · synced Jun 8, 2026