FDA.report

SS Triple SafeDepth Drill Ø1.8/Ø2.5/Ø3.2mm x 10mmL

Primary DI
07290116778013
Brand
SS Triple SafeDepth Drill Ø1.8/Ø2.5/Ø3.2mm x 10mmL
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
TSS1032
Published
2025-12-01
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
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290116778013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290116778013072901167780137290116778013

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
533289435
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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