FDA.reportPublic FDA data

NobelBiocare™ Tri-Lobe-compatible

Primary DI
00842092162460
Brand
NobelBiocare™ Tri-Lobe-compatible
Company
Preat Corporation
Model
8000630
Catalog number
8000630
Device description
NobelBiocare™ Tri-Lobe-compatible WP Engaging Verification Cylinder
Published
2023-08-16
Public version status
New
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142118000INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAEPrismatik Dentalcraft, Inc.2014-11-25NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092162460PackageGS110In Commercial Distribution
00842092101322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092162460008420921624608420921624600842092162460
00842092101322008420921013228420921013220842092101322

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. 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
true
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
00842092185391Preat7105407105402025-12-22
00842092185414Preat7105427105422025-12-22
00842092185421Preat7105437105432025-12-22
00842092185438Preat7105447105442025-12-22
00842092185445Preat7105457105452025-12-22
00842092185452Preat7105507105502025-12-22
00842092184257Preat7101717101712025-07-24
00842092184400Preat7100237100232025-07-24
00842092184417Preat7100247100242025-07-24
00842092184424Preat7100257100252025-07-24
00842092184448Preat7100327100322025-07-24
00842092184455Preat7100337100332025-07-24
00842092184462Preat7100347100342025-07-24
00842092184516Preat7102217102212025-07-24
00842092184561Preat7107117107112025-07-24
00842092184578Preat7107127107122025-07-24
00842092184585Preat7107137107132025-07-24
00842092184592Preat7107147107142025-07-24
00842092184608Preat7107157107152025-07-24
00842092184615Preat7107167107162025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22