FDA UDI
In Commercial Distribution
🇺🇸 United States
E-Tray
DI: 04260683220171
·
Model: RES-01-3114
·
Envisiontec GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- E-Tray
- Primary DI
- 04260683220171
- Version / Model
- RES-01-3114
- Catalog Number
- RES-01-3114
- Company Name
- Envisiontec GmbH
- Labeler DUNS
- 332025159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-07
- Public Version
- 2
- Public Version Date
- 2020-12-03
- Public Version Status
- Update
- Public Device Record Key
- df93d4f4-90e6-4762-87ba-f57089f9f79e
Device Description
E-Tray is a light-curing material for the additive manufacturing of individual dental impression trays and bite template bases
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 | 04260683220171 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit