FDA UDI
In Commercial Distribution
🇺🇸 United States
Renew Finishing System
DI: D798RSPFG0
·
Model: *RSP
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Renew Finishing System
- Primary DI
- D798RSPFG0
- Version / Model
- *RSP
- Catalog Number
- *RSP
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-30
- Public Version
- 3
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- af0fab77-9b07-4857-812e-54d46b6a5d95
Device Description
The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite. The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva. The #383 Point is the second step in the Renew Finishing System Points. This is the Friction Grip Finishing Point.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJL | Bur, Dental | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16668 | Carbide dental bur, reusable | A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798RSPFG0 | HIBCC | ||||
| Package | D798RSPFG3 | HIBCC | 3 | In Commercial Distribution | ||
| Package | D798RSPFG2 | HIBCC | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 6307734009
- [email protected]