FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SET CANAL SEALER PASTE
K Number: K862129
·
Decision Jul 22, 1986
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
10
Review Days
48
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Basic Information
- Device Name
- SET CANAL SEALER PASTE
- K Number
- K862129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Endo Technic Corp.
- Date Received
- June 4, 1986
- Decision Date
- July 22, 1986
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
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Other Clearances by Endo Technic Corp.
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|---|---|---|---|
| K990908 | MILLENNIUM | May 27, 1999 | Substantially Equivalent |
| K971459 | DERMALASE | Jul 18, 1997 | Substantially Equivalent |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | Aug 24, 1994 | Substantially Equivalent |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | Mar 9, 1994 | Substantially Equivalent |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Feb 28, 1994 | Substantially Equivalent |
| K924058 | TROCAR | Mar 30, 1993 | Substantially Equivalent |
| K914825 | 1-125 ENDOSEED | Mar 19, 1992 | Substantially Equivalent |
| K910200 | LASER-35 | May 9, 1991 | Substantially Equivalent |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Feb 27, 1987 | Substantially Equivalent |