FDA.reportPublic FDA data

Prima

Primary DI
D76815063K0
Brand
Prima
Company
KEYSTONE DENTAL, INC.
Model
15063K
Device description
Surgical Kit
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
OFYDental implant surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D76815063K0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

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
Kit
true
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
07290116778662Zygomatic Surgical Kit, Standard Hex ADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-04-19
07290116770369Zygomatic surgical Kit, Standard Hex – TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2026-03-26
07290109308630Single TMA Open Tray TransferADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290109309927Guided Surgery Drills TRAYADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770000Guided Surgery Accessories TRAY– UNP&NPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770017Guided Surgery Accessories TRAY - RS ImplantsADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770024Guided Surgery Accessories TRAY– RP&WPADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116770291Guided Surgery Accessories KIT - UniFit Implants, TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772769Bone Autografting Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772776Bone Autografting Master SS Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772783OsseoSave Master NC Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116772790OsseoSave Master Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
07290116775494SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776507SS SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776514 SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776521SS SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116772967Bone Autografting Master SS Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773124OsseoSave Master Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116773285OsseoSave Master NC Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-26
07290116772806Bone Autografting Master KitADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-11-25
07640149888270TRITRI Dental Implants Int. AGOFY2025-11-10
07640149888324TRITRI Dental Implants Int. AGOFY2025-11-10
08435389826576COMPLETE SURGICAL BOX ADVANCED KITBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08435389828945STOP & GUIDE KIT; INTERNA IMPLANT; 3.0 PLATFORMBIOTECHNOLOGY INSTITUTE SLOFY2025-04-14
08809918259980Surgical Option KitOssvis Co., Ltd.OFY2025-02-25
08435451660466KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660473KLOCKNERSOADCO, S.L.OFY2025-02-14
08435451660480KLOCKNERSOADCO, S.L.OFY2025-02-14
08809918259959Surgical Master Kit2Ossvis Co., Ltd.OFY2024-11-22
08809918259928Surgical Simple Kit2Ossvis Co., Ltd.OFY2024-10-25