FDA.report

Implant Prosthetics

Primary DI
00842092117118
Brand
Implant Prosthetics
Company
PREAT CORPORATION
Model
8003751
Catalog number
8003751
Device description
Multi-Unit Titanium Screw (.050 Hex)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092117118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092117118008420921171188420921171180842092117118

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screwA non-sterile device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
805 202 3070lauren@preat.com
805 202 3070info@preat.com
+1 (800) 232-7732info@preat.com

Regulatory Flags

DUNS number
054875224
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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00842092187647Equator214290121429012026-02-25
00842092187654Equator214290221429022026-02-25
00842092186640Equator214299221429922026-02-06
00842092186657Equator214299621429962026-02-05
00842092186664Equator214200321420032026-02-05
00842092184028Preat7101067101062025-12-22
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00842092184141Preat7100567100562025-12-22
00842092184301Preat7100107100102025-12-22
00842092184370Preat7100207100202025-12-22
00842092184660Preat7100857100852025-12-22
00842092184677Preat7100867100862025-12-22
00842092184721Preat7100957100952025-12-22
00842092184738Preat7100967100962025-12-22
00842092184745Preat7101517101512025-12-22
00842092184783Preat7101557101552025-12-22
00842092184790Preat7101567101562025-12-22
00842092184844Preat7101457101452025-12-22

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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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