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SwissTEC Composite

FDA UDI

Class II (US FDA UDI)

by Coltène/Whaledent AG

Identity

Trade Name
SwissTEC Composite FDA UDI
Generic Name
Dental composite resin FDA UDI
Model / Reference
5606 FDA UDI

Identifiers

Catalog Number
5606 FDA UDI
Primary DI / UDI-DI
J00656060 FDA UDI
510(k) Number
K974465 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
Not 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

For dental professionals, the SwissTEC Composite device provides a reliable and versatile option for luting agents, liners, bases, pulp-capping materials, pit/fissure sealants, and direct restorative materials. With its self-, light-, or dual-cured polymerization of dimethacrylate resins, it offers excellent setting reaction properties.

Cleared under the same submission

K974465 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 26f98765-cd41-4a7c-9305-be8f15de199d 37 fields · synced Jul 24, 2026