FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MM-SEAL
K Number: K123276
·
Decision Mar 10, 2014
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
11
Review Days
507
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Basic Information
- Device Name
- MM-SEAL
- K Number
- K123276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro-Mega Societe Anonyme
- Date Received
- October 19, 2012
- Decision Date
- March 10, 2014
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Micro-Mega Societe Anonyme
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|---|---|---|---|
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| K042171 | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 | Nov 10, 2004 | Substantially Equivalent |
| K971350 | SERIES XE, SERIES SE, SERIES TE | Jun 4, 1997 | Substantially Equivalent |
| K961275 | SIRIUS 10, 10L, 40, 40L | Jan 17, 1997 | Substantially Equivalent |
| K961235 | SIRIUS 180, 180L, 230, 230L | Jan 8, 1997 | Substantially Equivalent |
| K961494 | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE | Jun 26, 1996 | Substantially Equivalent |
| K961076 | MM 324 | Apr 26, 1996 | Substantially Equivalent |
| K950555 | J SINGLE USE HEAD AND JD REUSABLE HANDLE | Dec 28, 1995 | Substantially Equivalent |
| K951272 | RELACS 7000 | May 12, 1995 | Substantially Equivalent |