| Primary Device ID | D716PUSINE41 |
| NIH Device Record Key | 95712e6f-879a-4247-b15c-3465497b24b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProUltra SINE |
| Version Model Number | PUSINE4 |
| Catalog Number | PUSINE4 |
| Company DUNS | 942778564 |
| Company Name | TULSA DENTAL PRODUCTS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com | |
| Phone | +1(800)662-1202 |
| tulsa.orders@dentsply.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D716PUSINE41 [Primary] |
| ELC | Scaler, ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
[D716PUSINE41]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2026-01-05 |
| Device Publish Date | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE Tip #6 |
| D716PUSINE51 | ProUltra SINE Tip #5 |
| D716PUSINE41 | ProUltra SINE Tip #4 |
| D716PUSINE31 | ProUltra SINE Tip #3 |
| D716PUSINE161 | ProUltra SINE Tips 1-6 |