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Preat

FDA UDI

Class I (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Preat FDA UDI
Generic Name
Dental laboratory mandrel FDA UDI
Device Name
Preci-Clix OD DDS starter kit - 2 x 1291 radicular PRECI-CLIX RTI ball attachments - 1 x 1226 set of 3 reamers - 1 x 1222 insertion tool - 1 x IMP-XS-042 screwdriver - 1 x RE H 2 impression tool (2 pcs) - 1 x RE H 14 model analogue (2 pcs) - 1 x 1234 replacement females (3 x 2 pcs) FDA UDI
Model / Reference
0101299 FDA UDI
Description
Preci-Clix OD DDS starter kit - 2 x 1291 radicular PRECI-CLIX RTI ball attachments - 1 x 1226 set of 3 reamers - 1 x 1222 insertion tool - 1 x IMP-XS-042 screwdriver - 1 x RE H 2 impression tool (2 pcs) - 1 x RE H 14 model analogue (2 pcs) - 1 x 1234 replacement females (3 x 2 pcs) FDA UDI

Identifiers

Catalog Number
0101299 FDA UDI
Primary DI / UDI-DI
00842092108482 FDA UDI
FDA Product Code
EGG FDA UDI
NDP FDA UDI
GMDN Term
Dental laboratory mandrel 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

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

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

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI 63bb86ce-c45a-43ff-8648-32d1c4a7aafa 36 fields · synced Jun 6, 2026