FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRIADENT ESTHETICAP
K Number: K050208
·
Decision Jun 14, 2005
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
23
Review Days
137
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
- FRIADENT ESTHETICAP
- K Number
- K050208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International
- Date Received
- January 28, 2005
- Decision Date
- June 14, 2005
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dentsply International
| K Number | Device Name | ||
|---|---|---|---|
| K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | Dec 11, 2012 | Substantially Equivalent |
| K061580 | ECLIPSE WAX REMOVER | Jul 28, 2006 | Substantially Equivalent |
| K060837 | IN-OVATION C | Apr 10, 2006 | Substantially Equivalent |
| K053368 | INTERPROXIMAL REDUCTION SYSTEM | Mar 29, 2006 | Substantially Equivalent |
| K052370 | CP BRACKET SYSTEM | Nov 1, 2005 | Substantially Equivalent |
| K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE | Aug 12, 2005 | Substantially Equivalent |
| K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING | May 11, 2005 | Substantially Equivalent |
| K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Feb 23, 2005 | Substantially Equivalent |
| K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | Jun 24, 2004 | Substantially Equivalent |
| K041335 | PTM SYSTEM | Jun 16, 2004 | Substantially Equivalent |