FDA UDI
In Commercial Distribution
🇺🇸 United States
BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT
DI: 10190886000649
·
Model: M965K-01
·
G & H Wire Company, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT
- Primary DI
- 10190886000649
- Version / Model
- M965K-01
- Company Name
- G & H Wire Company, Inc.
- Labeler DUNS
- 831465641
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 68cca65e-a590-49fe-beb0-566e369e1b2e
Device Description
An advanced formula designed as a multipurpose final cement for the cementation of orthodontic bands. The cement is radio-opaque and has cariostatic properties by naturally releasing fluoride. Kit contents: 18gm powder, 17.5ml liquid, 50 sheet mixing pads, measuring scoop, instructions.
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16704 | Glass ionomer dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). 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 | 10190886000649 | GS1 |
Customer Contacts
- Phone
- +1 317-346-6655
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981036 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 75 Degrees Fahrenheit