FDA.report

Prima

Primary DI
D76815076K0
Brand
Prima
Company
KEYSTONE DENTAL, INC.
Model
15076K
Device description
Tap
Published
2019-05-08
Public version status
Update
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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D76815076K0PrimaryHIBCC0

GMDN Terms

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.

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
false
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
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415271Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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08800055792217Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20