FDA UDI
In Commercial Distribution
🇺🇸 United States
Tray Adhesive
DI: D701DTA22
·
Model: DTA2
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tray Adhesive
- Primary DI
- D701DTA22
- Version / Model
- DTA2
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-23
- Public Version
- 1
- Public Version Date
- 2021-10-01
- Public Version Status
- New
- Public Device Record Key
- 942cde4a-dd8b-42d1-bb1a-a041e976e2fc
Device Description
Tray Adhesive 29.5 mL bottle
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 |
|---|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | 872.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16658 | Dental impression material adhesive | A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D701DTA22 | HIBCC |