FDA UDI
In Commercial Distribution
🇺🇸 United States
Obtura Spartan
DI: 00816168020152
·
Model: 931-116
·
OBTURA SPARTAN ENDODONTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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
- Obtura Spartan
- Primary DI
- 00816168020152
- Version / Model
- 931-116
- Catalog Number
- 931-116
- Company Name
- OBTURA SPARTAN ENDODONTICS
- Labeler DUNS
- 078371330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 4
- Public Version Date
- 2022-09-27
- Public Version Status
- Update
- Public Device Record Key
- 8746b198-771a-424e-b9d0-aecde16b151c
Device Description
Tip Set KiS 1D-6D Contains: 931-011 Tip KiS-1D Diamond DI# 00816168020183 931-012 Tip KiS-2D Diamond DI# 00816168020190 931-013 Tip KiS-3D Diamond DI# 00816168020206 931-014 Tip KiS-4D Diamond DI# 00816168020213 931-015 Tip KiS-5D Diamond DI# 00816168020220 931-016 Tip KiS-6D Diamond DI# 00816168020237
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46035 | Ultrasonic dental scaling/debridement system handpiece tip, endodontic | An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816168020152 | GS1 |