← Back to catalogue

Preat

FDA UDI

Class I (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Preat FDA UDI
Generic Name
Dental precision attachment fitting/adjustment tool FDA UDI
Device Name
Sagix Starter Kit Cast-to Metal Male. Kit contains:. 4 cast-on NOPRAX males. 4 yellow females (normal retention). 4 white females (reduced retention). 4 red females (increased retention). 4 duplicating dummies/processing females. 1 universal paralleling mandrel. 1 universal insertion tool FDA UDI
Model / Reference
0101303 FDA UDI
Description
Sagix Starter Kit Cast-to Metal Male. Kit contains:. 4 cast-on NOPRAX males. 4 yellow females (normal retention). 4 white females (reduced retention). 4 red females (increased retention). 4 duplicating dummies/processing females. 1 universal paralleling mandrel. 1 universal insertion tool FDA UDI

Identifiers

Catalog Number
0101303 FDA UDI
Primary DI / UDI-DI
00842092108635 FDA UDI
FDA Product Code
EGG FDA UDI
NDP FDA UDI
GMDN Term
Dental precision attachment fitting/adjustment tool FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3165 FDA UDI
872.3980 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI c7509c19-ed0a-432f-97ca-f973af7d29e3 36 fields · synced May 30, 2026