Preat

FDA UDI

Class II (US FDA UDI)

by PREAT Corporation

Identity

Trade Name: Preat FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: BioHorizons®-compatible 4.5mm Clix Complete Ball Abutment 1mm Kit contains 1 BioHorizons®-compatible 4.5mm Clix Complete Ball Abutment 1mm 1 Clix Female Yellow Female- Standard. 1 Clix White Females- Reduced. 1 Clix Red Females- Increased. 1 Clix Metal Housing FDA UDI
Model / Reference: 1600551C FDA UDI
Description: BioHorizons®-compatible 4.5mm Clix Complete Ball Abutment 1mm Kit contains 1 BioHorizons®-compatible 4.5mm Clix Complete Ball Abutment 1mm 1 Clix Female Yellow Female- Standard. 1 Clix White Females- Reduced. 1 Clix Red Females- Increased. 1 Clix Metal Housing FDA UDI

Identifiers

Catalog Number: 1600551C FDA UDI
Primary DI / UDI-DI: 00842092170168 FDA UDI
FDA Product Code: NHA FDA UDI
EGG FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
872.3165 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental implant suprastructure, permanent, preformed Resilient dental precision attachment Sliding dental precision attachment

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: PREAT Corporation

Sources (1)

FDA UDI b386e22c-603a-40f5-8a3d-d742c45e4ab1 35 fields · synced Jun 8, 2026