Varios
GUDID 04589551387359
NAKANISHI INC.
Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal Ultrasonic dental scaling/debridement system handpiece tip, periodontal| Primary Device ID | 04589551387359 |
| NIH Device Record Key | c8f48a2e-b523-43db-b59c-31c1f3b2819a |
| Commercial Distribution Discontinuation | 2023-07-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Varios |
| Version Model Number | P20 |
| Company DUNS | 690710546 |
| Company Name | NAKANISHI INC. |
| Device Count | 6 |
| DM Exempt | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560264563018 [Primary] |
| GS1 | 04589551387359 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113530
FDA Product Code
| ELC | Scaler, ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
[04589551387359]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2022-12-13 |
On-Brand Devices [Varios]
| 04560264563766 | V10-E |
| 04560264563759 | V-P26L |
| 04560264563742 | V-P26R |
| 04560264563704 | G9 |
| 04560264563698 | P11L |
| 04560264563681 | P11R |
| 04560264563629 | P26L |
| 04560264563612 | P26R |
| 04560264563544 | E12 |
| 04560264563537 | E11 |
| 04560264563520 | V-S33 |
| 04560264563513 | V-S3 |
| 04560264563506 | V-S1 |
| 04560264563490 | V-N51 |
| 04560264563483 | V-N50 |
| 04560264563476 | V-S53 |
| 04560264563469 | V-S52 |
| 04560264563452 | V-S51 |
| 04560264563445 | V-S50 |
| 04560264563438 | G28 |
| 04560264563421 | G26 |
| 04560264563414 | G25 |
| 04560264563407 | G22 |
| 04560264563391 | G21 |
| 04560264563384 | E8 |
| 04560264563377 | E7 |
| 04560264563360 | E6 |
| 04560264563353 | E5 |
| 04560264563346 | E4 |
| 04560264563322 | P41 |
| 04560264563315 | P40 |
| 04560264563308 | P25L |
| 04560264563292 | P25R |
| 04560264563285 | P21L |
| 04560264563278 | P21R |
| 04560264563018 | P20 |
| 04560264563551 | P10 |
| 04560264563247 | P1 |
| 04560264563230 | G13 |
| 04560264563223 | G12 |
| 04560264563216 | G11 |
| 04560264563209 | G6 |
| 04560264563193 | G5 |
| 04560264563186 | G4 |
| 04560264563179 | G3 |
| 04560264563162 | G2 |
| 04560264563155 | G1 |
| 04560264563148 | G8 |
| 04560264562714 | U files 33mm ISO 35 |
| 04560264562707 | U files 33mm ISO 30 |
Trademark Results [Varios]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIOS 85861738 not registered Dead/Abandoned |
New England Footwear, LLC 2013-02-27 |
 VARIOS 78734285 3524222 Live/Registered |
NAKANISHI INC. 2005-10-17 |
 VARIOS 76422659 2804182 Dead/Cancelled |
Roland Corporation 2002-06-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.