Belmont Quolis 5000 Series Dental Unit
FDA 510(k) K072273 · Takara Belmont USA, Inc.
510(k) numberK072273
Submission
- Device name
- Belmont Quolis 5000 Series Dental Unit
- Applicant
- Takara Belmont USA, Inc.
West Cadwell, NJ, US - Received
- August 15, 2007
- Decision date
- December 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRD – Unit, Operative Dental, Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6640
- Specialty
- Dental
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.
Other 510(k)s with product code NRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042266 | AcclaimNRD · Special | Air Techniques, Inc. | 08/31/2004SE |
More from Air Techniques, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102456 | Intraoral Belsensor GoldMUH · Traditional | 12/15/2011SE |
| K062529 | Belmax CM Model X168MUH · Traditional | 10/05/2006SE |
| K041834 | Adr Plus Ssxi Imaging Device for X-Ray Systems Such AS X-Caliber, X-Caliber CM, Ana-Bel…MUH · Traditional | 12/03/2004SE |
| K042260 | Phot-X II, Model 303EHD · Traditional | 09/07/2004SE |
| K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMEHD · Traditional | 06/02/2004SE |
Questions and answers
When was Belmont Quolis 5000 Series Dental Unit cleared by the FDA?
Belmont Quolis 5000 Series Dental Unit (K072273) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 127 days after the submission was received.
What is the product code of K072273?
The FDA product code is NRD – Unit, Operative Dental, Accessories, a Class I (low risk) device regulated under 21 CFR 872.6640.