FDA UDI
In Commercial Distribution
🇺🇸 United States
DuoTEMP
DI: J00670900
·
Model: 7090
·
Coltène/Whaledent AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DuoTEMP
- Primary DI
- J00670900
- Version / Model
- 7090
- Catalog Number
- 7090
- Company Name
- Coltène/Whaledent AG
- Labeler DUNS
- 480017482
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 4
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- d6e82599-41e8-447e-a179-59c3bffaa676
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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16710 | Zinc phosphate dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. It typically includes some additional fillers/components. 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 | J00670900 | HIBCC |
Customer Contacts
- Phone
- +41717575300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072604 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius