FLEXITIME XTREME HEAVY TRAY REF.12X50 ML
- Primary DI
- J014660196840
- Brand
- FLEXITIME XTREME HEAVY TRAY REF.12X50 ML
- Company
- Heraeus Kulzer GmbH
- Model
- 66019684
- Catalog number
- 66019684
- Device description
- Material, Impression
- Published
- 2016-09-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ELW | MATERIAL, IMPRESSION |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELW | Material, Impression | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| J014660196840 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Polyether dental impression material | An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. |
Regulatory Flags
- DUNS number
- 315666321
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| J014660007821 | IOT yellow 96 | 66000782 | 66000782 | 2024-09-09 |
| J014660009051 | BITE REG INTRAORAL TIP CD 96 | 66000905 | 66000905 | 2024-09-09 |
| J014660019700 | DISPENSING GUN 2 (1:1/2:1) | 66001970 | 66001970 | 2024-09-09 |
| J014660019881 | Mixing Tip yellow 1:1 48 | 66001988 | 66001988 | 2024-09-09 |
| J014660019891 | Mixing Tip green 1:1 48 | 66001989 | 66001989 | 2024-09-09 |
| J014660036390 | FLEXITIME HEAVY TRAY 1 X 50 ML SAMPLE | 66003639 | 66003639 | 2024-09-09 |
| J014660036400 | FLEXITIME MONO PHASE 1 X 50 ML SAMPLE | 66003640 | 66003640 | 2024-09-09 |
| J014660036410 | FLEXITIME CORRECT FLOW 1 X 50 ML SAMPLE | 66003641 | 66003641 | 2024-09-09 |
| J014660082900 | PROVIL NOVO L. F CD2 1X(2X50ML) | 66008290 | 66008290 | 2024-09-09 |
| J014660082910 | PROVIL NOVO MED. F CD2 1X(2X50ML) | 66008291 | 66008291 | 2024-09-09 |
| J014660082920 | PROVIL NOVO MED. R CD2 1X(2X50ML) | 66008292 | 66008292 | 2024-09-09 |
| J014660082930 | PROVIL NOVO MONO F CD 2 1X(2X50ML) | 66008293 | 66008293 | 2024-09-09 |
| J014660082940 | PROVIL NOVO MONO R CD2 1X(2X50ML) | 66008294 | 66008294 | 2024-09-09 |
| J014660360830 | Dispensing Gun 10:1 | 66036083 | 66036083 | 2024-09-09 |
Other Devices Sharing Product Codes
xxx.xxx