FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CHEMFIL ROCK
DI: D010606065901
·
Model: 60606590
·
Dentsply De Trey GmbH
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CHEMFIL ROCK
- Primary DI
- D010606065901
- Version / Model
- 60606590
- Catalog Number
- 60606590
- Company Name
- Dentsply De Trey GmbH
- Labeler DUNS
- 315471722
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- 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
- bc340f6d-c80f-437e-bb73-a3e8c064f968
- Distribution End Date
- 2022-12-31
Device Description
CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. The capsule extruder is used for the extrusion and direct application of the capsules. With its supporting accessory (Capsule Extruder) it can be classified as a convenience kit.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 2 |
| EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER | Dental | 872.3765 | 2 |
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | Dental | 872.3250 | 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 | D010606065901 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 442 | Milligram | |
| Total Volume | 0.12 | Milliliter | |
| Device Size Text, specify | Powder | ||
| Device Size Text, specify | Liquid |