FDA UDI
In Commercial Distribution
🇺🇸 United States
Phase II
DI: D798PJB0
·
Model: PJB
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Phase II
- Primary DI
- D798PJB0
- Version / Model
- PJB
- Catalog Number
- PJB
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 83eaa8bc-a300-4fdc-9cd4-e05125f1e698
Device Description
Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. The highly-filled paste provides a strong mechanical bond with metal and ceramic bracket bases. 18g Base Paste B in Jar
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
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 | D798PJB0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K875142 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage at room temperature (15-30 Degrees C)