FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K Number: K111348
·
Decision Jul 22, 2011
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
47
Review Days
70
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RE / STASIS (TM) GINGIVAL RETRACTION PASTE
- K Number
- K111348
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Centrix, Inc.
- Date Received
- May 13, 2011
- Decision Date
- July 22, 2011
- Product Code
- MVL
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MVL), ordered by most recent decision date.
CyClean Cord
FDA 510(k)
FDA Unclassified
·Unknown
One-Stop
FDA 510(k)
FDA Unclassified
·Unknown
Retraxil
FDA 510(k)
FDA Unclassified
·Unknown
Stasis Gel
FDA 510(k)
FDA Unclassified
·Unknown
Gingi-Aid Gel
FDA 510(k)
FDA Unclassified
·Unknown
VOCO Retraction Paste
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Centrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250714 | FluoroDose Varnish | Nov 21, 2025 | Substantially Equivalent |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Oct 27, 2023 | Substantially Equivalent |
| K152826 | NoCord | May 27, 2016 | Substantially Equivalent |
| K140144 | BENDA WEDGE | Jul 8, 2014 | Substantially Equivalent |
| K120176 | SENZZZZZ AWAY | Jul 25, 2012 | Substantially Equivalent |
| K092384 | LIQUICORD | Nov 4, 2009 | Substantially Equivalent |
| K091380 | CORDCAP | Jul 30, 2009 | Substantially Equivalent |
| K021131 | CHLORAPREP | Sep 26, 2002 | Substantially Equivalent |
| K021146 | D/SENSE 1-STEP | Jul 2, 2002 | Substantially Equivalent |
| K010133 | VERSALUX | Apr 5, 2001 | Substantially Equivalent |