FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RELIANCE S.E.P.
K Number: K071688
·
Decision Sep 7, 2007
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
32
Review Days
79
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
- RELIANCE S.E.P.
- K Number
- K071688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reliance Orthodontic Products, Inc.
- Date Received
- June 20, 2007
- Decision Date
- September 7, 2007
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Reliance Orthodontic Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210349 | TKO Composite Bite Turbo Gel | Jul 20, 2021 | Substantially Equivalent |
| K210945 | Ultra SEP | Jul 8, 2021 | Substantially Equivalent |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Apr 27, 2020 | Substantially Equivalent |
| K161684 | Quantum LB | Oct 6, 2016 | Substantially Equivalent |
| K130237 | PONTIC PAINT | Apr 5, 2013 | Substantially Equivalent |
| K123348 | CLEAR ALIGNER ADHESIVE | Feb 28, 2013 | Substantially Equivalent |
| K111814 | PADLOCK | Sep 14, 2011 | Substantially Equivalent |
| K101951 | LIGHT CURE RETAINER | Oct 26, 2010 | Substantially Equivalent |
| K083051 | FLOWTAIN & FLOWTAIN LV | Feb 20, 2009 | Substantially Equivalent |
| K073243 | LED PRO SEAL | Feb 8, 2008 | Substantially Equivalent |