FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
K Number: K151123
·
Decision Mar 3, 2016
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
14
Applicant Total
9
Review Days
310
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Basic Information
- Device Name
- Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
- K Number
- K151123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pac-Dent International, Inc.
- Date Received
- April 28, 2015
- Decision Date
- March 3, 2016
- Product Code
- PEM
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| PEM | Dental Barriers And Sleeves | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEM), ordered by most recent decision date.
Dental Barrier and Sleeves
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Dental Barrier and Sleeves
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Minitube Dentasleeve Protective Barrier Sleeves
FDA 510(k)
FDA Class 2
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Other Clearances by Pac-Dent International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162662 | GingiDent Gingival Retraction Paste | Oct 20, 2017 | Substantially Equivalent |
| K160577 | PacEndo Chlorhexidine | Jul 25, 2016 | Substantially Equivalent |
| K153528 | PacEndo EDTA | Feb 1, 2016 | Substantially Equivalent |
| K151852 | PacEndo Sodium Hyprochlorite | Nov 10, 2015 | Substantially Equivalent |
| K151150 | Elements | Jul 28, 2015 | Substantially Equivalent |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Mar 9, 2015 | Substantially Equivalent |
| K141422 | PROFLUORO FLUORIDE VARNISH | Sep 30, 2014 | Substantially Equivalent |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Aug 13, 2013 | Substantially Equivalent |