FDA.report

ANKYLOS®

Primary DI
07392532218972
Brand
ANKYLOS®
Company
Dentsply Implants Manufacturing GmbH
Model
31033625
Catalog number
31033625
Device description
Insert for Prosthetic Ratchet Screwdriver 1.0 mm Hex 15 Ncm
Published
2022-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532266843Direct MarkingGS10
07392532218972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532266843073925322668437392532266843
07392532218972073925322189727392532218972

GMDN Terms

TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
344038836
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
false
Expiration date on label
false
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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07392532207112SIMPLANT®54500179545001792026-03-10
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07392532236051SIMPLANT®54500197545001972026-03-10
07392532236020SIMPLANT®54500214545002142026-03-10
07392532281266ATLANTIS®68020074680200742025-12-18
07392532281280ATLANTIS®68020076680200762025-12-18
07392532215278ANKYLOS®31021100310211002020-11-18
07392532215285ANKYLOS®31021110310211102020-11-18
07392532215339ANKYLOS®31021160310211602020-11-18
07392532215353ANKYLOS®31021180310211802020-11-18
07392532215865ANKYLOS®31021630310216302020-11-18
07392532215896ANKYLOS®31021647310216472020-11-18
07392532215988ANKYLOS®31021660310216602020-11-18
07392532216572ANKYLOS®31022540310225402020-11-18

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