IMPLANT 20:1

Primary DI
E27660437020
Brand
IMPLANT 20:1
Company
SIRONA Dental Systems GmbH
Model
6043702
Device description
IMPLANT 20:1
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27660437020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, remotely-drivenA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device does not incorporate a power source (e.g., an AC-powered motor). The rotational power is transferred from the power source to the endpiece via mechanical components (e.g., chains, gears, shafts) incorporated in the handpiece or via an external flexible drive system (e.g., a Bowden cable); the endpiece(s) are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
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