FDA UDI
In Commercial Distribution
🇺🇸 United States
Megatray
DI: EMD11MYDVOKS2
·
Model: 2022/11/05
·
MEGADENTA Dentalprodukte GmbH
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Megatray
- Primary DI
- EMD11MYDVOKS2
- Version / Model
- 2022/11/05
- Company Name
- MEGADENTA Dentalprodukte GmbH
- Labeler DUNS
- 316153928
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- 2527f524-219a-4613-b92c-d252903df02a
Device Description
Light curing composite for the production of individual impression trays and base plates
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | EMD11MYDVOKRS1 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMD11MYDVOKS2 | HIBCC | ||||
| Package | EMD11MYDVOKBL1 | HIBCC | 1 | In Commercial Distribution | ||
| Package | EMD11MYDVOKTR1 | HIBCC | 1 | In Commercial Distribution | ||
| Package | EMD11MYDVOKRS11 | HIBCC | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +4935284530
- [email protected]