FDA.reportPublic FDA data

Preat Implant Prosthetics

Primary DI
00842092161708
Brand
Preat Implant Prosthetics
Company
Implants and Attachments, Inc.
Model
9004750
Catalog number
9004750
Device description
Nobel Active/Conical 3.0mm Titanium Screw
Published
2022-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220823000Preat AbutmentsPreat Corporation2022-10-26NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092161708PackageGS110In Commercial Distribution
00842092161630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092161708008420921617088420921617080842092161708
00842092161630008420921616308420921616300842092161630

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092101063NobelBiocare™ Tri-Lobe-compatible 800055180005512023-08-10
00842092177105Preat Implant Prosthetics900373290037322022-11-03
00842092161784Preat Implant Prosthetics900703090070302022-11-03
00842092161814Preat Implant Prosthetics900723090072302022-11-03
00842092161845Preat Implant Prosthetics900703590070352022-11-03
00842092161876Preat Implant Prosthetics900723590072352022-11-03
00842092157169Preat Implant Prosthetics900643090064302022-10-31
00842092157213Preat Implant Prosthetics900653090065302022-10-31
00842092159132Preat Implant Prosthetics900665090066502022-10-31
00842092157268Preat Implant Prosthetics900663090066302022-10-31
00842092159149Preat Implant Prosthetics900675090067502022-10-31
00842092157312Preat Implant Prosthetics900673090067302022-10-31
00842092157350Preat Implant Prosthetics900683090068302022-10-31
00842092157381Preat Implant Prosthetics900643590064352022-10-31
00842092157411Preat Implant Prosthetics900653590065352022-10-31
00842092157442Preat Implant Prosthetics900663590066352022-10-31
00842092157473Preat Implant Prosthetics900673590067352022-10-31
00842092157503Preat Implant Prosthetics900683590068352022-10-31
00842092159576Preat Implant Prosthetics900583090058302022-11-01
00842092159606Preat Implant Prosthetics900593090059302022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
07290112854148NAUNIQA DENTAL LTDNHA2026-07-19
07290112854407NAUNIQA DENTAL LTDNHA2026-07-19
07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
07290118177357NAUNIQA DENTAL LTDNHA2026-07-19
07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092185391PreatPreat CorporationNHA2025-12-22