FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Sealer Solvent
K Number: K241354
·
Decision Aug 27, 2024
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
40
Applicant Total
8
Review Days
106
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Basic Information
- Device Name
- Sealer Solvent
- K Number
- K241354
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inter-Med, Inc.
- Date Received
- May 13, 2024
- Decision Date
- August 27, 2024
- Product Code
- KJJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | FDA unclassified | Unknown |
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Other Clearances by Inter-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253337 | REGEN Bioactive Cement | Apr 15, 2026 | Substantially Equivalent |
| K241489 | ReminGel | Jan 8, 2025 | Substantially Equivalent |
| K241457 | Vista BC Putty | Aug 28, 2024 | Substantially Equivalent |
| K221811 | Vista BC Sealer | Nov 21, 2022 | Substantially Equivalent |
| K211721 | PS System | Dec 2, 2021 | Substantially Equivalent |
| K112250 | CHX=CHX PLUS | Oct 28, 2011 | Substantially Equivalent |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | Apr 3, 2009 | Substantially Equivalent |