Stern Root Anchor® Standard FG Diamond Bur
GUDID 00841549106767
The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth. This device is a Friction grip (FG) diamond bur for standard female.
STERNGOLD DENTAL LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00841549106767 |
| NIH Device Record Key | c1790a28-f6cc-4703-b701-5972ae814805 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stern Root Anchor® Standard FG Diamond Bur |
| Version Model Number | 833110 |
| Company DUNS | 124763728 |
| Company Name | STERNGOLD DENTAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com | |
| Phone | 401-871-3489 |
| maria.rao@sterngold.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549106767 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K950213
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
[00841549106767]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-01-08 |
| Device Publish Date | 2017-05-15 |
On-Brand Devices [Stern Root Anchor® Standard FG Diamond Bur]
| 08415491020598 | The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S |
| 00841549106767 | The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S |
Trademark Results [Stern Root Anchor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERN ROOT ANCHOR 85352302 4151629 Live/Registered |
STERNGOLD DENTAL LLC 2011-06-21 |
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