FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISODAN
K Number: K010415
·
Decision Jul 23, 2001
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
21
Review Days
161
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Basic Information
- Device Name
- ISODAN
- K Number
- K010415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Specialites Septodont
- Date Received
- February 12, 2001
- Decision Date
- July 23, 2001
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Specialites Septodont
| K Number | Device Name | ||
|---|---|---|---|
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Oct 9, 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 |