FDA UDI
In Commercial Distribution
🇺🇸 United States
Renew System
DI: D798DB0
·
Model: DB
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Renew System
- Primary DI
- D798DB0
- Version / Model
- DB
- Catalog Number
- DB
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-25
- Public Version
- 3
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- 5047c581-fdf4-485b-b2ac-8862f54cc5fe
Device Description
INDICATIONS FOR USE: 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. Renew Diamond Burs #129 A medium abrasion diamond bur recommended for roughening and preparing plastic, composite restorations and metal surfaces.
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 16670 | Diamond dental bur, reusable | A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. 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 | D798DB0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in ambient conditions.