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Ep®

FDA UDI

Class I (US FDA UDI)

by Biomet 3i, Llc

Identity

Trade Name
EP® FDA UDI
Generic Name
Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Device Name
IMPLANT EP® PICK-UP COPING 5MM(D) X 7.5MM(P) FDA UDI
Model / Reference
WIP57 FDA UDI
Description
IMPLANT EP® PICK-UP COPING 5MM(D) X 7.5MM(P) FDA UDI

Identifiers

Primary DI / UDI-DI
00844868017684 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

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 implant suprastructure, temporary, preformed, single-use

The EP device is a prefabricated dental implant suprastructure, temporary and single-use, designed to provide a temporary intermediate fixture level between a dental implant and a temporary prosthesis/restoration during the oral soft-tissue healing and sculpturing period prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration.

Similar devices

Also classified as Dental implant suprastructure, temporary, preformed, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet 3i, Llc

Sources (1)

  • FDA UDI d78a86a4-7949-4deb-af0a-dc4c7337ce2c 35 fields · synced Jun 29, 2026