FDA.report

ANKYLOS®

Primary DI
07392532220562
Brand
ANKYLOS®
Company
Dentsply Implants Manufacturing GmbH
Model
31037541
Catalog number
31037541
Device description
Seating Instrument for C/X Implants, HXSS short motor
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
07392532220562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532220562073925322205627392532220562

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

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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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