FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELEMENTS OBTURATION UNIT
K Number: K031664
·
Decision Apr 28, 2004
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
5
Applicant Total
3
Review Days
335
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
- ELEMENTS OBTURATION UNIT
- K Number
- K031664
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Endo/Analytic
- Date Received
- May 29, 2003
- Decision Date
- April 28, 2004
- Product Code
- EKR
- 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 |
|---|---|---|---|
| EKR | Plugger, Root Canal, Endodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKR), ordered by most recent decision date.
B&L L-BETA, MODEL WL-B1
FDA 510(k)
FDA Class 1
·Dental
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC ROOT CANAL PLUGGER
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC ROOT CANAL PLUGGER FINGER-
FDA 510(k)
FDA Class 1
·Dental
MCSPADDEN CONDENSOR
FDA 510(k)
FDA Class 1
·Dental