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DIRECTscan™ Adapter Double Wing-F

FDA UDI

Class I (US FDA UDI)

by Apollo Implant Components Sp Z O O

Identity

Trade Name
DIRECTscan™ Adapter Double Wing-F FDA UDI
Generic Name
Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Model / Reference
DS2000-09F FDA UDI

Identifiers

Primary DI / UDI-DI
05904890607477 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant abutment analog, intraoral-scanning, 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant abutment analog, intraoral-scanning, single-use

DIRECTscan™ Adapter Double Wing-F by Apollo Implant Components Sp Z O O — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant abutment analog, intraoral-scanning, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apollo Implant Components Sp Z O O

Sources (1)

  • FDA UDI 1d398e7b-17c1-4196-bf2a-cc2fc4a27163 32 fields · synced May 30, 2026