FDA UDI
In Commercial Distribution
🇺🇸 United States
StarDental Instrument Solutions
DI: D7022656770
·
Model: 265677
·
DENTALEZ, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StarDental Instrument Solutions
- Primary DI
- D7022656770
- Version / Model
- 265677
- Company Name
- DENTALEZ, INC.
- Labeler DUNS
- 059010363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-05
- Public Version
- 1
- Public Version Date
- 2018-12-06
- Public Version Status
- New
- Public Device Record Key
- d5b11509-3564-4487-8cfd-5c011850a2af
Device Description
STARBRIGHT SINGLE LAMP CONTROL SYSTEM
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62745 | Medical device light source controller | A mains electricity (AC-powered) device intended to step down the electrical power from the mains to supply power to and provide control of (e.g., on/off) a light source associated with another medical device (e.g. surgical power tool). This controller may be operated through hand and/or foot controls. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7022656770 | HIBCC |
Customer Contacts
- Phone
- 1-866-383-4636
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K944271 | 000 |