FDA.report

Prima

Primary DI
D76815268K0
Brand
Prima
Company
KEYSTONE DENTAL, INC.
Model
15268K
Device description
Implant Driver
Published
2019-05-08
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D76815268K0PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

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