BioSonic
GUDID D661600142390
SUVI Elite Ultrasonic Scaler/Polisher
COLTENE/WHALEDENT INC
Ultrasonic dental scaling/debridement system| Primary Device ID | D661600142390 |
| NIH Device Record Key | 5bfce189-dd30-48a3-9633-c039fe9ed0c2 |
| Commercial Distribution Discontinuation | 2024-11-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BioSonic |
| Version Model Number | 60014239 |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com | |
| Phone | 3309168800 |
| info.us@coltene.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D661600142390 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130137
FDA Product Code
| ELC | Scaler, Ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
[D661600142390]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-07 |
| Device Publish Date | 2016-06-03 |
On-Brand Devices [BioSonic]
| D661600220470 | UC150 Cleaner Unit JAP Plug Type AJ |
| D661600219900 | UC150 Cleaner Unit AUS Plug Type I |
| D661600219890 | UC150 Cleaner Unit UK Plug Type G |
| D661600219880 | UC150 Cleaner Unit Euro Plug Type F |
| D661600219870 | UC150 Cleaner Unit USA Plug Type A |
| D661UCB20 | Small Parts Basket |
| D661UC960 | UC95 Full Size Basket |
| D661UC530 | Borosilicate Beaker |
| D661UC420 | Germicidal Solution - 16 oz |
| D661UC390 | Cement Remover Solution |
| D661UC380 | Germicidal Solution - 8 oz |
| D661UC3400 | Replacement Cover |
| D661UC340 | Plaster and Stone Remover |
| D661UC3351 | 2 Basket Section Inserts |
| D661UC3300 | Two Beaker Holder |
| D661UC3250 | Cassette Basket |
| D661UC320 | Enzymatic Solution |
| D661UC3151150 | Remote Digital Timer - UC300R |
| D661UC3110 | Twin FingerGuard Basket |
| D661UC3100 | Large FingerGuard Basket |
| D661UC300RB1150 | UC300 Ultrasonic Cleaner, Recessed 115V |
| D661UC300B1150 | UC300 Ultrasonic Cleaner 115V |
| D661UC300 | General Purpose Solution |
| D661UC155XD0 | UC125 Accessory Kit |
| D661UC1530 | Single Beaker Holder |
| D661UC152XD0 | 3/4 FingerGuard Basket |
| D661UC151XD0 | Full Size FingerGuard Basket |
| D661UC125B1150 | UC125 Ultrasonic Cleaner 115V |
| D661ST160 | Soaking Tray |
| D661600350620 | UC150 Cleaner Unit USA Plug Type A - No Heater |
| D661600220460 | UC150 Sealing Gasket |
| D661600220450 | UC150 LID |
| D661600220440 | UC150 Drain Hose |
| D661600220430 | UC150 Drain Filter |
| D661600220421 | UC150 Accessory Kit |
| D661600220410 | UC150 Beaker Holder |
| D661600220400 | UC150 Casset Basket |
| D661UC125LCD0 | UC125LCD |
| D661600196080 | Suvi Scaler Tip - PE40HS |
| D661600193280 | Suvi Subgingival Nozzle |
| D661600187660 | Suvi Focus Group - Blue |
| D661600187630 | Suvi Focus Grip - Lime |
| D661600184860 | Suvi Angled Air Nozzle |
| D661600184850 | Suvi 90 Degree Air Nozzle |
| D661600144570 | Suvi Wrench for File Holders |
| D661600144560 | Suvi Torque Tip Wrench |
| D661600144550 | Suvi Universal Plastic Tip Wrench |
| D661600144540 | Suvi Universal Tip Wrench |
| D661600143110 | Suvi Scaler Tip - IH1 |
| D661600143090 | Suvi Scaler Tip - FH2 |
Trademark Results [BioSonic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSONIC 86414451 4860841 Live/Registered |
Coltene/Whaledent Inc. 2014-10-03 |
 BIOSONIC 79080651 3960695 Dead/Cancelled |
Elster NV/SA 2010-02-18 |
 BIOSONIC 76271960 2647080 Dead/Cancelled |
K-2 Corporation 2001-06-15 |
 BIOSONIC 73790133 1575996 Live/Registered |
IPCO CORPORATION 1989-03-30 |
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