Pro-Select Platinum® S30920
GUDID D813S30921
PSP TIPS – L/R/STRT 3PK
DEN-MAT HOLDINGS, LLC
Ultrasonic dental scaling/debridement system| Primary Device ID | D813S30921 |
| NIH Device Record Key | 8cad1441-aaf0-429e-835f-417c88fc5c83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-Select Platinum® |
| Version Model Number | S30920 |
| Catalog Number | S30920 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 3 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from explosive substances and flammable materials |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use this product in presence of inflammable anesthetics or gases |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813S30920 [Unit of Use] |
| HIBCC | D813S30921 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964596
FDA Product Code
| ELC | Scaler, Ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D813S30921]
Liquid Chemical;Moist Heat or Steam Sterilization;High-level Disinfectant
[D813S30921]
Liquid Chemical;Moist Heat or Steam Sterilization;High-level Disinfectant
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Pro-Select Platinum®]
| D813S423510 | PSP HIGH-PRO UPGRADE KIT |
| D813S42350L0 | PSP STANDARD PACK LOANER |
| D813S423500 | PSP STANDARD PACK |
| D813S409010 | PSP Foot Pedal |
| D813S408710 | PSP LED Light Attachments |
| D813S408510 | PSP Irrigation Handpiece |
| D813S408010 | PSP SCALER HANDPIECE |
| D813S407500 | PSP 6 ft. Autoclave LED Cable |
| D813S309601 | PSP TIPS – UNIV STRT 3PK |
| D813S309500 | PSP TIP – UNIV RIGHT |
| D813S309400 | PSP TIP – UNIV LEFT |
| D813S309300 | PSP TIP – UNIV STRT |
| D813S30921 | PSP TIPS – L/R/STRT 3PK |
| D813S30500 | Transformer/Adapter + Wall Plug (Universal for PSP & PS3) |
| D81320540 | 23-Gauge Sideport Irrigation Cannulas (100/box) |
| D8131007730 | Tip Gauge/ Wrench |
| D8131005400 | Tip Grip |
Trademark Results [Pro-Select Platinum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRO-SELECT PLATINUM 78935815 3332785 Live/Registered |
Den-Mat Holdings, LLC 2006-07-24 |
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