FDA.reportPublic FDA data

Implant Prosthetics

Primary DI
00842092116906
Brand
Implant Prosthetics
Company
Preat Corporation
Model
8001250
Catalog number
8001250
Device description
Straumann Tissue Level RN/WN Titanium Screw
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092116906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092116906008420921169068420921169060842092116906

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092170199Preat9001230-109001230-102026-06-09
00842092174999Preat9003731-1009003731-1002026-06-09
00842092187722Preat7100033-27100033-22026-06-08
00842092117217Implant Prosthetics800165080016502016-09-16
00842092117491Implant Prosthetics800055080005502016-09-16
00842092110669FR Attachments070204007020402023-07-05
00842092112076Preat06000F906000F92022-10-25
00842092112113Preat Implant Prosthetics0600F130600F132023-07-03
00842092122396Preat Implant Prosthetics800123780012372022-11-22
00842092155844Implantlink090751009075102022-10-25
00842092167601Preat0600F160600F162022-10-25
00842092167618Preat060406606040662022-10-25
00842092172544Preat010900301090032022-10-24
00842092172551Preat010900501090052022-10-24
00842092175590Preat010200701020072022-10-25
00842092175606Preat010200801020082022-10-25
00842092176696Preci-Clix01004TI01004TI2022-10-27
00842092110577Mays020006002000602023-10-17
00842092110737Splintastik020000102000012023-10-17
00842092109281Preci 52010156101015612023-07-06

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Primary DI, Brand, Company table
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05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
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05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
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