FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO-ICE-PULP TESTER-THERMAL
K Number: K930764
·
Decision May 27, 1993
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
16
Review Days
104
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Basic Information
- Device Name
- ENDO-ICE-PULP TESTER-THERMAL
- K Number
- K930764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1720
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Hygenic Corp.
- Date Received
- February 12, 1993
- Decision Date
- May 27, 1993
- Product Code
- EAT
- 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 |
|---|---|---|---|
| EAT | Tester, Pulp | FDA class 2 | Dental |
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Other Clearances by The Hygenic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954990 | DENTAL DAM | Jan 26, 1996 | 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 |
| K863393 | ENDOCATER | Jun 11, 1987 | Substantially Equivalent |