FDA.reportPublic FDA data

OT-F1 Prosthetics

Primary DI
EOTM0123890010001
Brand
OT-F1 Prosthetics
Company
OT medical GmbH
Model
01-2389001000
Catalog number
01-2389001000
Device description
Cover Screw for dental Implant, made by Titanium, Diameter: 3,8mm. Compatible with Pitt Easy System
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EOTM0123890010001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
340998796
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EOTM0113310800001OT-F1 Implant TPS Surface01-133108000001-13310800002015-10-21
EOTM0113311000001OT-F1 Implant TPS Surface01-133110000001-13311000002015-10-21
EOTM0113311200001OT-F1 Implant TPS Surface01-133112000001-13311200002015-10-21
EOTM0113311400001OT-F1 Implant TPS Surface01-133114000001-13311400002015-10-21
EOTM0113311600001OT-F1 Implant TPS Surface01-133116000001-13311600002015-10-21
EOTM0113320800001OT-F1 Implant Nanoplast Surface01-133208000001-13320800002015-10-22
EOTM0113321000001OT-F1 Implant Nanoplast Surface01-133210000001-13321000002015-10-22
EOTM0113321200001OT-F1 Implant Nanoplast Surface01-133212000001-13321200002015-10-22
EOTM0113321400001OT-F1 Implant Nanoplast Surface01-133214000001-13321400002015-10-22
EOTM0113321600001OT-F1 Implant Nanoplast Surface01-133216000001-13321600002015-10-22
EOTM0113810800001OT-F1 Implant TPS Surface01-138108000001-13810800002015-10-21
EOTM0113811000001OT-F1 Implant TPS Surface01-138110000001-13811000002015-10-21
EOTM0113811200001OT-F1 Implant TPS Surface01-138112000001-13811200002015-10-21
EOTM0113811400001OT-F1 Implant TPS Surface01-138114000001-13811400002015-10-21
EOTM0113811600001OT-F1 Implant TPS Surface01-138116000001-13811600002015-10-21
EOTM0113820800001OT-F1 Implant Nanoplast Surface01-138208000001-13820800002015-10-22
EOTM0113821000001OT-F1 Implant Nanoplast Surface01-138210000001-13821000002015-10-22
EOTM0113821200001OT-F1 Implant Nanoplast Surface01-138212000001-13821200002015-10-22
EOTM0113821400001OT-F1 Implant Nanoplast Surface01-138214000001-13821400002015-10-22
EOTM0113821600001OT-F1 Implant Nanoplast Surface01-138216000001-13821600002015-10-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
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07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
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