FDA.reportPublic FDA data

Ditron Dental

Primary DI
07290109285863
Brand
Ditron Dental
Company
DITRON DENTAL LTD
Model
DISKit-C
Catalog number
DISKit-C
Device description
Stopper Drill Full Kit - Coated Drills
Published
2021-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous
OFYDental Implant Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2
OFYDental Implant Surgical TrayDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140728000MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PRDitron Precision, Ltd.2014-10-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109285863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109285863072901092858637290109285863

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97286711884info@ditrondental.com

Regulatory Flags#

DUNS number
531878633
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109284828Ditron Dental ITDL-300300ITDL-3003002025-05-22
07290109284835Ditron Dental ITDS-300290ITDS-3002902025-05-22
07290109284842Ditron Dental MMDL-300260MMDL-3002602025-05-22
07290109284880Ditron Dental SBCC-3500SBCC-35002025-05-22
07290109284897Ditron Dental TRC-C3020TRC-C30202025-05-22
07290109284903Ditron Dental TRO-C3011TRO-C30112025-05-22
07290109284910Ditron Dental TRO-C3033TRO-C30332025-05-22
07290109284927Ditron Dental TRO-C3010TRO-C30102025-05-22
07290109284934Ditron Dental TRO-C3030TRO-C30302025-05-22
07290122086720Ditron Dental TRC-C3022TRC-C30222025-05-22
07290109287263Ditron DentalSRA-SC3001SRA-SC30012025-04-09
07290109287270Ditron DentalSRA-TB4800SRA-TB48002025-04-09
07290109287287Ditron DentalSRA-TT4800SRA-TT48002025-04-09
07290109287294Ditron DentalTLI-LIB50TLI-LIB502025-04-09
07290109287300Ditron DentalTTI-C3500-08TTI-C3500-082025-04-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06