FDA UDI
In Commercial Distribution
🇺🇸 United States
StarDental
DI: D7022660650
·
Model: 266065
·
DENTALEZ, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StarDental
- Primary DI
- D7022660650
- Version / Model
- 266065
- Company Name
- DENTALEZ, INC.
- Labeler DUNS
- 059010363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-07
- Public Version
- 2
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- 8a19aa8c-ba2b-4d71-badb-6a0afe7187ee
Device Description
Star 500 Swivel, non-Fiber Optic
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45121 | Pneumatic dental handpiece coupler | A short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7022660650 | HIBCC |
Customer Contacts
- Phone
- 1-866-383-4636
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192412 | 000 |