FDA.reportPublic FDA data

TRI-OR

Primary DI
07290110722234
Brand
TRI-OR
Company
HI-TEC IMPLANTS LTD.
Model
TRI-OR 1.3-10mm
Catalog number
TRI-OR 1.3-10
Device description
DENTAL IMPLANT
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K941575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941575000SMOOTH FITHi-Tec Implants1994-11-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110722234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110722234072901107222347290110722234

GMDN Terms#

Term, Definition table
TermDefinition
Transmandibular implantA sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible. It is composed of a metal plate and transosteal pins or posts. The plate is held with retentive pins or screws fixed to the inferior border of the mandible, and supports the transosteal pins/posts that penetrate the full thickness of the mandible and project into the mouth in the inter-foraminal area.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600710917
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110729240HI-TEC IMPLANTSN-BBA-3N-BBA-32024-12-16
07290110729257HI-TEC IMPLANTSN-BBA-4N-BBA-42024-12-16
07290110729264HI-TEC IMPLANTSN-BBA-5N-BBA-52024-12-16
07290110729288HI-TEC IMPLANTSN-MU-1N-MU-12024-12-16
07290110729295HI-TEC IMPLANTSN-MU-2N-MU-22024-12-16
07290110729301HI-TEC IMPLANTSN-MU-3N-MU-32024-12-16
07290110729318HI-TEC IMPLANTSN-MU-4N-MU-42024-12-16
07290110729325HI-TEC IMPLANTSN-MU-17N-MU-172024-12-16
07290110729332HI-TEC IMPLANTSN-MU-30N-MU-302024-12-16
07290110729158HI-TEC IMPLANTSN-AATN-AAT2024-12-15
07290110729165HI-TEC IMPLANTSN-AAT-LN-AAT-L2024-12-15
07290110729172HI-TEC IMPLANTSN-ACA-1.5N-ACA-1.52024-12-15
07290110729189HI-TEC IMPLANTSN-ACA-2.5N-ACA-2.52024-12-15
07290110729196HI-TEC IMPLANTSN-ACA-3.5N-ACA-3.52024-12-15
07290110729202HI-TEC IMPLANTSN-ACA-4.5N-ACA-4.52024-12-15
07290110729219HI-TEC IMPLANTSN-ACA-PN-ACA-P2024-12-15
07290110729226HI-TEC IMPLANTSN-ANA-17-1.5N-ANA-17-1.52024-12-15
07290110729233HI-TEC IMPLANTSN-BBA-2N-BBA-22024-12-15
07290110729370HI-TEC IMPLANTSN-HC-4.5-3N-HC-4.5-32024-12-15
07290110729387HI-TEC IMPLANTSN-HC-4.5-4.5N-HC-4.5-4.52024-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014894Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014900Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014917Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014924Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014948Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014955Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014962Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014979Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014986Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06