FDA.reportPublic FDA data

Prima Plus

Primary DI
D76815788K0
Brand
Prima Plus
Company
KEYSTONE DENTAL, INC.
Model
15788K
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051614000PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSLifecore Biomedical, Inc.2005-09-09DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D76815788K0PrimaryHIBCC0

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.

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
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08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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