FDA UDI
In Commercial Distribution
🇺🇸 United States
TempoSIL 2
DI: J00636860
·
Model: 3686
·
Coltène/Whaledent AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TempoSIL 2
- Primary DI
- J00636860
- Version / Model
- 3686
- Catalog Number
- 3686
- 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
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- 70a1335d-f9e1-4234-ab07-1c0a297576cd
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 |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00636860 | HIBCC |
Customer Contacts
- Phone
- +41717575300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083304 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 23 Degrees Celsius