FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEMETRON A.2
K Number: K063116
·
Decision Dec 5, 2006
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
15
Review Days
54
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
- DEMETRON A.2
- K Number
- K063116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Dental Specialties
- Date Received
- October 12, 2006
- Decision Date
- December 5, 2006
- 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 Sybron Dental Specialties
| K Number | Device Name | ||
|---|---|---|---|
| K182826 | Ormco Spark Aligner System | Oct 11, 2018 | Substantially Equivalent |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Apr 21, 2017 | Substantially Equivalent |
| K160097 | Image Fast Set, Image Regular Set | Aug 5, 2016 | Substantially Equivalent |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | Jul 27, 2016 | Substantially Equivalent |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | May 6, 2016 | Substantially Equivalent |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Apr 14, 2016 | Substantially Equivalent |
| K151526 | Zone, ZoneFree, Zone A1 | Sep 10, 2015 | Substantially Equivalent |
| K151332 | Nexus Universal, Nexus Universal Chroma | Aug 17, 2015 | Substantially Equivalent |
| K150559 | Life Fast Set, Life Regular Set | Jun 19, 2015 | Substantially Equivalent |
| K143209 | SonicFill 2 | Feb 5, 2015 | Substantially Equivalent |