FDA UDI
In Commercial Distribution
🇺🇸 United States
SDC impression material (Zest)
DI: 00850007728243
·
Model: 200-0106
·
Access Dental Lab, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SDC impression material (Zest)
- Primary DI
- 00850007728243
- Version / Model
- 200-0106
- Company Name
- Access Dental Lab, LLC
- Labeler DUNS
- 054012763
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- ebe9663d-0a73-4437-aad0-4fb92e09ce83
Device Description
impression material used to create dental impressions
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
- MR Safe
- 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 |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48085 | Dental impression material kit, single-use | A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850007728243 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092319 | 000 |