FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIUM FLEXI-TOUGH
K Number: K854530
·
Decision Mar 4, 1986
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
16
Review Days
111
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Basic Information
- Device Name
- PREMIUM FLEXI-TOUGH
- K Number
- K854530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- The Hygenic Corp.
- Date Received
- November 13, 1985
- Decision Date
- March 4, 1986
- Product Code
- EGD
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
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Other Clearances by The Hygenic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954990 | DENTAL DAM | Jan 26, 1996 | Substantially Equivalent |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | May 27, 1993 | Substantially Equivalent |
| K905418 | GATES GLIDDEN DRILLS | Jul 25, 1991 | Substantially Equivalent |
| K911225 | TRAY DOUGH | Apr 17, 1991 | Substantially Equivalent |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | Mar 5, 1991 | Substantially Equivalent |
| K900301 | NOVUS BONDING AGENT | May 15, 1990 | Substantially Equivalent |
| K900844 | WEDJETS | Apr 16, 1990 | Substantially Equivalent |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | Jan 10, 1990 | Substantially Equivalent |
| K881826 | ENDO-ICE | Aug 23, 1988 | Substantially Equivalent for Some Indications |
| K873644 | PULP PEN | Oct 27, 1987 | Substantially Equivalent |