FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Insure® Universal; Insure® Universal Automix
K Number: K240714
·
Decision Jul 24, 2024
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
28
Review Days
131
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Basic Information
- Device Name
- Insure® Universal; Insure® Universal Automix
- K Number
- K240714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cosmedent, Inc.
- Date Received
- March 15, 2024
- Decision Date
- July 24, 2024
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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|---|---|---|---|
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| K172707 | Renamel Microfill | Dec 5, 2017 | Substantially Equivalent |
| K163480 | Renamel NANO +plus | Feb 24, 2017 | Substantially Equivalent |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Nov 20, 2009 | Substantially Equivalent |
| K070583 | NANO COMPOSITE | Apr 16, 2007 | Substantially Equivalent |
| K060881 | TEMPORARY CROWN & BRIDGE RESIN | May 16, 2006 | Substantially Equivalent |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Dec 16, 2005 | Substantially Equivalent |
| K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Oct 21, 2005 | Substantially Equivalent |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Dec 1, 2004 | Substantially Equivalent |