FDA.report

Genesis ACTIVE

Primary DI
D768GA715670
Brand
Genesis ACTIVE
Company
KEYSTONE DENTAL, INC.
Model
GA71567
Device description
Genesis Active Conical Implant Analog, Ø3.8 - 5 Pack
Published
2023-06-19
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D768GA715670PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)902-9272customersupport@keystonedental.com

Regulatory Flags

DUNS number
787471015
Device count
1
DM exempt
true
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D768G151000Genesis ACTIVEG151002023-06-19
D768G151010Genesis ACTIVEG151012023-06-19
D768G151020Genesis ACTIVEG151022023-06-19
D768G151030Genesis ACTIVEG151032023-06-19
D768G151040Genesis ACTIVEG151042023-06-19
D768G151050Genesis ACTIVEG151052023-06-19
D768G151060Genesis ACTIVEG151062023-06-19
D768G151070Genesis ACTIVEG151072023-06-19
D768G151080Genesis ACTIVEG151082023-06-19
D768G151090Genesis ACTIVEG151092023-06-19
D768G151100Genesis ACTIVEG151102023-06-19
D768G151110Genesis ACTIVEG151112023-06-19
D768G151120Genesis ACTIVEG151122023-06-19
D768G151130Genesis ACTIVEG151132023-06-19
D768G151140Genesis ACTIVEG151142023-06-19
D768G151150Genesis ACTIVEG151152023-06-19
D768G151160Genesis ACTIVEG151162023-06-19
D768G151170Genesis ACTIVEG151172023-06-19
D768G151180Genesis ACTIVEG151182023-06-19
D768G151200Genesis ACTIVEG151202023-06-19

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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800076423664URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423671URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
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08800076423725URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24