O-Ring Implant Abutments 1600823C

GUDID 00842092168202

O-Ring Complete Abutment Branemark RP x 3mm 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

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Primary Device ID	00842092168202
NIH Device Record Key	674333d4-1937-492e-9624-7f44088b88c1
Commercial Distribution Status	In Commercial Distribution
Brand Name	O-Ring Implant Abutments
Version Model Number	1600823C
Catalog Number	1600823C
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	00842092168202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K183518

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous