FDA UDI
In Commercial Distribution
🇺🇸 United States
O-Bite
DI: EDMG9997650
·
Model: 999765
·
DMG Chemisch-Pharmazeutische Fabrik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- O-Bite
- Primary DI
- EDMG9997650
- Version / Model
- 999765
- Catalog Number
- 999765
- Company Name
- DMG Chemisch-Pharmazeutische Fabrik GmbH
- Labeler DUNS
- 320744915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 78df8e94-375d-4348-a40d-949c376b3530
Device Description
Bite registration material automix system. Fresh hardness for optimal occlusion. Content: 4 cartridges @50ml paste, Accessories
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
- Yes
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EDMG9997658 | HIBCC | 6 | In Commercial Distribution | ||
| Package | EDMG9997651 | HIBCC | 4 | In Commercial Distribution | ||
| Primary | EDMG9997650 | HIBCC |
Customer Contacts
- Phone
- 201-894-5505
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K810825 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect against exposure to direct sunlight! Do not store in the fridge or freezer!
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit