FDA.reportPublic FDA data

Genesis ACTIVE

Primary DI
D768G151010
Brand
Genesis ACTIVE
Company
KEYSTONE DENTAL, INC.
Model
G15101
Device description
Genesis DLC Final Tapered Drill Ø3.5 x 8.5 mm
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D768G151010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.5Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)902-9272customersupport@keystonedental.com

Regulatory Flags#

DUNS number
787471015
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D76802538901111K0Prima02-541901111K2017-12-13
D76802541901111K0Prima02-540901111K2017-12-13
D76802550901111K0Prima15789K2017-12-13
D76815300K0Prima15300K15300K2016-02-04
D76815301K0Prima15301K15301K2016-02-04
D76815302K0Prima15302K15302K2016-02-04
D76815303K0Prima15303K15303K2016-02-04
D76815304K0Prima15304K15304K2016-02-04
D76815305K0Prima15305K15305K2016-02-04
D76815306K0Prima15306K15306K2016-02-04
D76815307K0Prima15307K15307K2016-02-04
D76815308K0Prima15308K15308K2016-02-04
D76815309K0Prima15309K15309K2016-02-04
D76815310K0Prima15310K15310K2016-02-04
D76815311K0Prima15311K15311K2016-02-04
D76815312K0Prima15312K15312K2016-02-04
D76815313K0Prima15313K15313K2016-02-04
D76815314K0Prima15314K15314K2016-02-04
D76815315K0Prima15315K15315K2016-02-04
D76815316K0Prima15316K15316K2016-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116660141Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-11
07290114713245prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
07290114713252prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
00887919581703DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-28
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27