FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K Number: K012427
·
Decision Oct 9, 2001
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
21
Review Days
70
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
- PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
- K Number
- K012427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1720
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialites Septodont
- Date Received
- July 31, 2001
- Decision Date
- October 9, 2001
- Product Code
- EAT
- 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 |
|---|---|---|---|
| EAT | Tester, Pulp | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAT), ordered by most recent decision date.
THERMIQUE
FDA 510(k)
FDA Class 2
·Dental
ELEMENTS DIAGNOSTIC UNIT
FDA 510(k)
FDA Class 2
·Dental
CHILLIT
FDA 510(k)
FDA Class 2
·Dental
ENDO ANALYZER, MODEL 8005, MODIFIED
FDA 510(k)
FDA Class 2
·Dental
ENDO ANALYZER, MODEL 8005
FDA 510(k)
FDA Class 2
·Dental
SYSTEM B HEAT SOURCE
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Specialites Septodont
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K920692 | SEPTOCALCINE ULTRA | Apr 21, 1992 | 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 |