FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CHEMFIL ROCK
DI: D010606065911
·
Model: 60606591
·
Dentsply De Trey GmbH
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- CHEMFIL ROCK
- Primary DI
- D010606065911
- Version / Model
- 60606591
- Catalog Number
- 60606591
- Company Name
- Dentsply De Trey GmbH
- Labeler DUNS
- 315471722
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2023-01-05
- Public Version Status
- Update
- Public Device Record Key
- 6c261840-981a-482a-8a88-1678c308ee10
- Distribution End Date
- 2022-12-31
Device Description
CHEMFIL ROCK A1 REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 2 |
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | Dental | 872.3250 | 2 |
| EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER | Dental | 872.3765 | 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 | D010606065911 | HIBCC | ||||
| Unit of Use | D010606065910 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Liquid | ||
| Total Volume | 0.12 | Milliliter | |
| Weight | 442 | Milligram | |
| Device Size Text, specify | Powder |