FDA.report

Prima

Primary DI
D76815651K0
Brand
Prima
Company
KEYSTONE DENTAL, INC.
Model
15651K
Device description
Surgical Kit
Published
2019-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OFYDental implant surgical tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D76815651K0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
787471015
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
08809918273634Surgical Simple Kit3Ossvis Co., Ltd.OFY2024-10-25
08809918273641Lilivis Guide Full KitOssvis Co., Ltd.OFY2024-10-25
04260516874885SIC invent Dental Implant SystemsSIC invent AGOFY2024-10-18
08809918249981Lili Guide KitOssvis Co., Ltd.OFY2024-08-01