FDA.report

Ditron Dental

Primary DI
07290109285702
Brand
Ditron Dental
Company
DITRON DENTAL LTD
Model
TMAL-200260
Catalog number
TMAL-200260
Device description
Long Motor Mount Driver Hex 2.42
Published
2021-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109285702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109285702072901092857027290109285702

GMDN Terms

TermDefinition
Basket endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a single, double, and/or triple contiguous cylinder(s) that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+97286711884info@ditrondental.com

Regulatory Flags

DUNS number
531878633
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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07290109287270Ditron DentalSRA-TB4800SRA-TB48002025-04-09
07290109287287Ditron DentalSRA-TT4800SRA-TT48002025-04-09
07290109287294Ditron DentalTLI-LIB50TLI-LIB502025-04-09
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07290109287317Ditron DentalTTI-C3500-15TTI-C3500-152025-04-09
07290109287324Ditron DentalTTI-C3500-25TTI-C3500-252025-04-09
07290109287331Ditron DentalTTI-C3500-35TTI-C3500-352025-04-09
07290109287348Ditron DentalTTI-C3500-45TTI-C3500-452025-04-09
07290109287355Ditron DentalTTI-C3501-08TTI-C3501-082025-04-09
07290109287362Ditron DentalTTI-C3501-15TTI-C3501-152025-04-09
07290109287379Ditron DentalTTI-C3501-25TTI-C3501-252025-04-09
07290109287386Ditron DentalTTI-C3501-35TTI-C3501-352025-04-09
07290109287393Ditron DentalTTI-C3501-45TTI-C3501-452025-04-09
07290109287409Ditron DentalTTI-C4500-08TTI-C4500-082025-04-09
07290109287416Ditron DentalTTI-C4500-15TTI-C4500-152025-04-09
07290109287423Ditron DentalTTI-C4500-25TTI-C4500-252025-04-09
07290109287430Ditron DentalTTI-C4500-35TTI-C4500-352025-04-09
07290109287447Ditron DentalTTI-C4501-08TTI-C4501-082025-04-09
07290109287454Ditron DentalTTI-C4501-15TTI-C4501-152025-04-09

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