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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
Intramucosal dental implant FDA UDI
Device Name
Direct Abutment™ EV Heal Cap 3.3 FDA UDI
Model / Reference
25310 FDA UDI
Description
Direct Abutment™ EV Heal Cap 3.3 FDA UDI

Identifiers

Catalog Number
25310 FDA UDI
Primary DI / UDI-DI
07392532144691 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Intramucosal dental implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Intramucosal dental 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 Intramucosal dental 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 2291593b-3bf4-4963-81fa-c4428737cd42 36 fields · synced Jun 8, 2026