FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
K Number: K980543
·
Decision Apr 14, 1998
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
279
Review Days
61
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
- DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
- K Number
- K980543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Intl.
- Date Received
- February 12, 1998
- Decision Date
- April 14, 1998
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dentsply Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Feb 22, 2013 | Substantially Equivalent |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Mar 27, 2008 | Substantially Equivalent |
| K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Mar 14, 2007 | Substantially Equivalent |
| K070019 | CARRARA VOLUMIA | Jan 26, 2007 | Substantially Equivalent |
| K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Jun 26, 2006 | Substantially Equivalent |
| K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Sep 2, 2005 | Substantially Equivalent |
| K051707 | ECLIPSE BONDING AGENT | Jul 15, 2005 | Substantially Equivalent |
| K051463 | XENO ADHESIVE WITH ACTIVATOR | Jul 12, 2005 | Substantially Equivalent |
| K051462 | MODIFICATION TO: CERCON BASE | Jun 24, 2005 | Substantially Equivalent |
| K050880 | DYRACT EXTRA RESTORATIVE | Apr 22, 2005 | Substantially Equivalent |