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Astra

FDA UDI

Class I (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Astra FDA UDI
Generic Name
Dental implant suprastructure reamer guiding pin FDA UDI
Device Name
Astra® EV-compatible 3.6 Guide Pin FDA UDI
Model / Reference
8006551 FDA UDI
Description
Astra® EV-compatible 3.6 Guide Pin FDA UDI

Identifiers

Catalog Number
8006551 FDA UDI
Primary DI / UDI-DI
00842092126974 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant suprastructure reamer guiding pin 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure reamer guiding pin

Astra by PREAT Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure reamer guiding pin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI e2d0780e-899f-4cef-8dd2-a31f9c4b5721 35 fields · synced Jun 1, 2026