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ASTRA TECH Implant System® EV

FDA UDI

Class II (US FDA UDI)

by Dentsply Implants Manufacturing GmbH

Identity

Trade Name
ASTRA TECH Implant System® EV FDA UDI
Generic Name
Transgingival implant FDA UDI
Device Name
Multibase EV Abutment Head with holder FDA UDI
Model / Reference
26192 FDA UDI
Description
Multibase EV Abutment Head with holder FDA UDI

Identifiers

Catalog Number
26192 FDA UDI
Primary DI / UDI-DI
07392532185847 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Transgingival implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transgingival implant

ASTRA TECH Implant System® EV by Dentsply Implants Manufacturing GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transgingival implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply Implants Manufacturing GmbH

Sources (1)

  • FDA UDI 5697e260-c245-4ac0-a2e0-abb884115b6e 36 fields · synced May 31, 2026