FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEPTOCALCINE ULTRA
K Number: K920692
·
Decision Apr 21, 1992
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
21
Review Days
67
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
- SEPTOCALCINE ULTRA
- K Number
- K920692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialites Septodont
- Date Received
- February 14, 1992
- Decision Date
- April 21, 1992
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJK), ordered by most recent decision date.
Bright Cavity Liner
FDA 510(k)
FDA Class 2
·Dental
3M VitCal Liner/Base
FDA 510(k)
FDA Class 2
·Dental
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
FDA 510(k)
FDA Class 2
·Dental
CleaniCal
FDA 510(k)
FDA Class 2
·Dental
LC ResinCal PC
FDA 510(k)
FDA Class 2
·Dental
Parkell Desensitizer Gel
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Specialites Septodont
| K Number | Device Name | ||
|---|---|---|---|
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Oct 9, 2001 | Substantially Equivalent |
| K010415 | ISODAN | Jul 23, 2001 | Substantially Equivalent |
| K982773 | QUICKSET LIQUID AND POWDER | Nov 3, 1998 | Substantially Equivalent |
| K982671 | SECURALLOY | Oct 19, 1998 | Substantially Equivalent |
| K980633 | ENDOSOLV E | May 1, 1998 | Substantially Equivalent |
| K915467 | CIMPAT S DENTAL CEMENT | Feb 3, 1992 | Substantially Equivalent |
| K915466 | SEPTOPACK TEMPORARY FILLING | Feb 3, 1992 | Substantially Equivalent |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 7, 1991 | Substantially Equivalent |
| K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | Oct 9, 1991 | Substantially Equivalent |
| K913574 | SEPTOCAL CAVITY LINER | Sep 30, 1991 | Substantially Equivalent |