FDA UDI
In Commercial Distribution
🇺🇸 United States
Assure Plus All Surface Bonding Resin
DI: D798PLUS2ML0
·
Model: PLUS2ML
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Assure Plus All Surface Bonding Resin
- Primary DI
- D798PLUS2ML0
- Version / Model
- PLUS2ML
- Catalog Number
- PLUS2ML
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-13
- Public Version
- 3
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- df80deed-3c24-493c-81e8-6d9964f7028e
Device Description
Assure® Plus All Surface Bonding Resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. Assure® Plus All Surface Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer. 2 ml bottle size
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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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 | D798PLUS2ML0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature (15-30 degrees C) Protect from heat and light. Avoid evaporation.