FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FotoDent® tray
DI: E239D353001
·
Model: D35300
·
Dreve Dentamid GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FotoDent® tray
- Primary DI
- E239D353001
- Version / Model
- D35300
- Catalog Number
- D35300
- Company Name
- Dreve Dentamid GmbH
- Labeler DUNS
- 388000846
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-19
- Public Version
- 2
- Public Version Date
- 2023-04-25
- Public Version Status
- Update
- Public Device Record Key
- a4e93284-8d72-4787-bc00-541662a2e68e
- Distribution End Date
- 2023-04-24
Device Description
No.
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
- 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 |
|---|---|---|---|---|
| EBH | MATERIAL, IMPRESSION TRAY, RESIN | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58106 | Dental impression tray material | A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E239D353001 | HIBCC |
Customer Contacts
- Phone
- +49230388070
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 28 Degrees Celsius