FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IBOND NEXT GENERATION
K Number: K051006
·
Decision Jun 7, 2005
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
10
Review Days
48
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
- IBOND NEXT GENERATION
- K Number
- K051006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer,GmbH
- Date Received
- April 20, 2005
- Decision Date
- June 7, 2005
- 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 Heraeus Kulzer,GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K083652 | IBOND TOTAL ETCH | Jan 21, 2009 | Substantially Equivalent |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | Apr 21, 2008 | Substantially Equivalent |
| K073554 | NEUN | Feb 4, 2008 | Substantially Equivalent |
| K062515 | RETENTION FLOW OPAQUE | Nov 22, 2006 | Substantially Equivalent |
| K050085 | OSTEOPAL V | Sep 14, 2005 | Substantially Equivalent |
| K050854 | PALACOS LV+G | Jul 7, 2005 | Substantially Equivalent |
| K050855 | PALAMED G | Jul 7, 2005 | Substantially Equivalent |
| K042199 | TRANSLUX POWER BLUE | Sep 8, 2004 | Substantially Equivalent |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Mar 1, 2004 | Substantially Equivalent |