FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE DENT
DI: 10810339031005
·
Model: RTAN
·
BGSS Company Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
35
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Basic Information
- Brand Name
- SAFE DENT
- Primary DI
- 10810339031005
- Version / Model
- RTAN
- Company Name
- BGSS Company Inc.
- Labeler DUNS
- 828474952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 35
- 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
- 788b8770-d0d8-4497-bc4a-fd6425f5ef3b
Device Description
RTAN Registration Tray ANTERIOR Inner box 35 pcs
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 |
|---|---|---|---|---|
| EHY | Tray, Impression, Preformed | Dental | 872.6880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16350 | Dental impression tray, single-use | A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810339031015 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10810339031005 | GS1 | ||||
| Unit of Use | 00810339031008 | GS1 |