FDA UDI
In Commercial Distribution
🇺🇸 United States
LCR RETAINER PASTE TIPS
DI: D8281330621
·
Model: 1330621
·
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
11
Basic Information
- Brand Name
- LCR RETAINER PASTE TIPS
- Primary DI
- D8281330621
- Version / Model
- 1330621
- Company Name
- FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
- Labeler DUNS
- 113352686
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 11
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a2a5a37f-f2cb-465a-adad-7e5ff413b69c
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8281330621 | HIBCC | ||||
| Unit of Use | D82813306212 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K894564 | 000 |