O-Ring Implant Abutments 1600822C

GUDID 00842092168196

O-Ring Complete Abutment Neoss 4.1mm x 2mm Kit contains: 1 O-Ring Metal Retainer Standard #3 (00842092107669) 1 O-Ring Ball Abutment Neoss 4.1mm x 1mm (00842092114520) 1 O-Ring Red Processing Ring #3 (00842092133835) 3 O-Ring Black Rings Standard #3 (00842092168165)

PREAT CORPORATION

Dental implant suprastructure, permanent, preformed

Primary Device ID	00842092168196
NIH Device Record Key	5d73cae0-45cf-48b6-945c-1a8661c0b33b
Commercial Distribution Status	In Commercial Distribution
Brand Name	O-Ring Implant Abutments
Version Model Number	1600822C
Catalog Number	1600822C
Company DUNS	054875224
Company Name	PREAT CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842092168196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183518

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00842092168196]

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[00842092168196]

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[00842092168196]

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[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

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[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

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[00842092168196]

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[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

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[00842092168196]

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[00842092168196]

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[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

[00842092168196]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-16
Device Publish Date	2022-09-08

On-Brand Devices [O-Ring Implant Abutments]

00842092115688	O-Ring Ball Abutment Branemark RP x 5mm
00842092114704	O-Ring Ball Abutment TSV 4.5 x 6mm
00842092114698	O-Ring Ball Abutment TSV 4.5 x 5mm
00842092114681	O-Ring Ball Abutment TSV 4.5 x 4mm
00842092114674	O-Ring Ball Abutment TSV 4.5 x 3mm
00842092114667	O-Ring Ball Abutment TSV 4.5 x 2mm
00842092114650	O-Ring Ball Abutment TSV 4.5 x .5mm
00842092114643	O-Ring Ball Abutment TSV 3.5 x 6mm
00842092114636	O-Ring Ball Abutment TSV 3.5 x 5mm
00842092114629	O-Ring Ball Abutment TSV 3.5 x 4mm
00842092114612	O-Ring Ball Abutment TSV 3.5 x 3mm
00842092114605	O-Ring Ball Abutment TSV 3.5 x 2mm
00842092114599	O-Ring Ball Abutment TSV 3.5 x 1mm
00842092114582	O-Ring Ball Abutment Neoss 4.1mm x 7mm
00842092114575	O-Ring Ball Abutment Neoss 4.1mm x 6mm
00842092114568	O-Ring Ball Abutment Neoss 4.1mm x 5mm
00842092114551	O-Ring Ball Abutment Neoss 4.1mm x 4mm
00842092114544	O-Ring Ball Abutment Neoss 4.1mm x 3mm
00842092114537	O-Ring Ball Abutment Neoss 4.1mm x 2mm
00842092114520	O-Ring Ball Abutment Neoss 4.1mm x 1mm
00842092112762	O-Ring Complete Abutment Zimmer TSV 3.5 x 2mm
00842092112755	O-Ring Complete Abutment Zimmer TSV 3.5 x 1mm
00842092111734	O-Ring Complete Abutment Branemark RP x 6mm
00842092111727	O-Ring Complete Abutment Branemark RP x 5mm
00842092111710	O-Ring Complete Abutment Branemark RP x 4mm
00842092111703	O-Ring Complete Abutment Branemark RP x 3mm
00842092111697	O-Ring Complete Abutment Branemark RP x 2mm
00842092111680	O-Ring Complete Abutment Branemark RP x 1mm
00842092111673	O-Ring Complete Abutment Zimmer TSV 4.5 x 6mm
00842092111666	O-Ring Complete Abutment Zimmer TSV 4.5 x 5mm
00842092111659	O-Ring Complete Abutment Zimmer TSV 4.5 x 4mm
00842092111642	O-Ring Complete Abutment Zimmer TSV 4.5 x 3mm
00842092111635	O-Ring Complete Abutment Zimmer TSV 4.5 x 2mm
00842092111628	O-Ring Complete Abutment Zimmer TSV 4.5 x .5mm
00842092111611	O-Ring Complete Abutment Zimmer TSV 3.5 x 6mm
00842092111604	O-Ring Complete Abutment Zimmer TSV 3.5 x 5mm
00842092111598	O-Ring Complete Abutment Zimmer TSV 3.5 x 4mm
00842092111581	O-Ring Complete Abutment Zimmer TSV 3.5 x 3mm
00842092168202	O-Ring Complete Abutment Branemark RP x 3mm Kit contains: 1 O-Ring Metal Retainer Standard #3 (0
00842092168196	O-Ring Complete Abutment Neoss 4.1mm x 2mm Kit contains: 1 O-Ring Metal Retainer Standard #3 (00
00842092168172	O-Ring Complete Abutment Neoss 4.1mm x 1mm Kit contains: 1 O-Ring Metal Retainer Standard #3 (00

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