Prima 45303K
GUDID 453D76803K0
Zi Coping
KEYSTONE DENTAL, INC.
Dental implant suprastructure, permanent, preformed| Primary Device ID | 453D76803K0 |
| NIH Device Record Key | 64c6997b-33d5-44d3-a48c-12a3dbbc858d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prima |
| Version Model Number | 45303K |
| Catalog Number | 45303K |
| Company DUNS | 787471015 |
| Company Name | KEYSTONE DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(781)328-3515 |
| cyoung@keystonedental.com | |
| Phone | +1(781)328-3515 |
| cyoung@keystonedental.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | 453D76803K0 [Primary] |
FDA Product Code
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-02-11 |
On-Brand Devices [Prima]
Trademark Results [Prima]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.