FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE DENT
DI: 00810339031480
·
Model: A90141S
·
BGSS Company Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SAFE DENT
- Primary DI
- 00810339031480
- Version / Model
- A90141S
- Company Name
- BGSS Company Inc.
- Labeler DUNS
- 828474952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 1
- Public Version Date
- 2024-05-09
- Public Version Status
- New
- Public Device Record Key
- 8c1f9af7-f7e2-462e-a810-d8b7fbeb7e9c
Device Description
A90141S FLOURIDE TRAY DUAL ARCH SMALL "bag 100pcs"
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
- 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 |
|---|---|---|---|---|
| KMT | Tray, Fluoride, Disposable | Dental | 872.6870 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63350 | Teeth whitening tray | A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810339031497 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00810339031480 | GS1 | ||||
| Unit of Use | 00810339031473 | GS1 |