FDA UDI
In Commercial Distribution
🇺🇸 United States
White Bite
DI: 00850056330244
·
Model: L5
·
White Bite, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- White Bite
- Primary DI
- 00850056330244
- Version / Model
- L5
- Catalog Number
- L5
- Company Name
- White Bite, Inc.
- Labeler DUNS
- 174136221
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-10-27
- Public Version
- 1
- Public Version Date
- 2025-11-04
- Public Version Status
- New
- Public Device Record Key
- 2c355ca9-c179-4d48-8508-e24924f999fc
Device Description
Pediatric Strip Crown Form Lower Cuspid 5
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
- 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 |
|---|---|---|---|---|
| KCQ | Tube Impression And Matrix | Dental | 872.6570 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42344 | Dental mould | A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056330244 | GS1 | ||||
| Unit of Use | 10850056330241 | GS1 |