FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ascent 3D
K Number: K150585
·
Decision Dec 31, 2015
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
31
Review Days
297
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ascent 3D
- K Number
- K150585
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CAO Group, Inc.
- Date Received
- March 9, 2015
- Decision Date
- December 31, 2015
- Product Code
- EBZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBZ), ordered by most recent decision date.
Curing Light (M-Cure 6)
FDA 510(k)
FDA Class 2
·Dental
Demi Pro
FDA 510(k)
FDA Class 2
·Dental
Bluemoon
FDA 510(k)
FDA Class 2
·Dental
LED Curing Lights (DB686 HALO)
FDA 510(k)
FDA Class 2
·Dental
LED Curing Light (C01-X, C02-X)
FDA 510(k)
FDA Class 2
·Dental
LOOP LED Curing Light System (CLK01)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by CAO Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254197 | Picasso Pro Diode Laser (002-00460) | Mar 11, 2026 | Substantially Equivalent |
| K201904 | Monet Curing Laser | Nov 24, 2020 | Substantially Equivalent |
| K201475 | Ultimate Contour, Ultimate Contour Mini | Oct 28, 2020 | Substantially Equivalent |
| K181602 | Pioneer Elite Diode Laser | Sep 10, 2019 | Substantially Equivalent |
| K181614 | Sterling Supreme Diode Laser | Sep 10, 2019 | Substantially Equivalent |
| K181601 | Precise SHP Diode Laser | Sep 9, 2019 | Substantially Equivalent |
| K171052 | Ultimate Contour, Ultimate Contour Mini | Oct 20, 2017 | Substantially Equivalent |
| K171986 | Sterling Supreme Diode Laser | Sep 22, 2017 | Substantially Equivalent |
| K160413 | Sterling 5W Diode Laser | Sep 21, 2016 | Substantially Equivalent |
| K142223 | Pilot Pro Diode Laser | Sep 12, 2014 | Substantially Equivalent |