FDA UDI
In Commercial Distribution
🇺🇸 United States
Excel
DI: D798EUERS0
·
Model: EUERS
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Excel
- Primary DI
- D798EUERS0
- Version / Model
- EUERS
- Catalog Number
- EUERS
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-14
- Public Version
- 2
- Public Version Date
- 2020-07-24
- Public Version Status
- Update
- Public Device Record Key
- adc567c9-2800-4bc6-8a61-b5c6501e8043
Device Description
Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regular Screw Syringe Kit contains in 2 X 6g Excel Paste A Screw syringes, 2 X Excel paste B in screw syringes, 1 X 9g Etchant, 1 7cc Bonding Resin A and B and mixing accessories. This kit contains Fluoride Bonding Resin and Non Fluoride Adhesives
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 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 | D798EUERS0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K875141 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature (15-30 Degrees C).