FDA.reportPublic FDA data

Genesis

Primary DI
D768G716080
Brand
Genesis
Company
KEYSTONE DENTAL, INC.
Model
G71608
Device description
Quad Driver
Published
2019-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101545000GENESIS IMPLANT SYSTEMKeystone Dental2010-10-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D768G716080PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(781)328-3313sshahid@keystonedental.com
+1(866)902-9272info@keystonedental.com

Regulatory Flags#

DUNS number
787471015
Device count
1
Lot or batch
true
No natural rubber latex
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
08800076476356TruBite ScopeTruabutment Korea Co.,LtdNDP2026-11-03
08800076476486TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476493TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476509TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476516TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
07290109308654Single TMA Snap-On TransferADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770383IRIS™, Burnout anti rotation cap red (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07640169734823BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736056BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736063BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736070BiodentaBiodenta Swiss AGNDP2026-10-30
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234384HELICAL DRILL Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMSin Sistema de Implante Nacional S/ANDP2026-10-30
08050038833271RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833745RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833752RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833769RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833776RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833783RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30