FDA UDI
In Commercial Distribution
🇺🇸 United States
Laminated Bite Wafers-Wax
DI: D8453003102
·
Model: 3003102
·
Denplus Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Laminated Bite Wafers-Wax
- Primary DI
- D8453003102
- Version / Model
- 3003102
- Catalog Number
- 3003102
- Company Name
- Denplus Inc
- Labeler DUNS
- 202016064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-21
- Public Version
- 1
- Public Version Date
- 2021-09-29
- Public Version Status
- New
- Public Device Record Key
- 473ec03c-830c-4699-b944-5c042eb08a2e
Device Description
Laminated Bite Wafers-Wax, White, 35 units
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGD | Wax, Dental, Intraoral | Dental | 872.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38602 | Bite registration rim wax | A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8453003102 | HIBCC |