FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
K Number: K840237
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
15
Applicant Total
9
Review Days
76
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Basic Information
- Device Name
- MAX-I-PROBE PERIODONTAL ENDODONTIC PROB
- K Number
- K840237
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew, Mpl Division
- Date Received
- January 20, 1984
- Decision Date
- April 5, 1984
- Product Code
- EIC
- 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 |
|---|---|---|---|
| EIC | Syringe, Periodontic, Endodontic, Irrigating | FDA class 1 | Dental |
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Other Clearances by Smith & Nephew, Mpl Division
| K Number | Device Name | ||
|---|---|---|---|
| K843314 | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE | Sep 27, 1984 | Substantially Equivalent |
| K841280 | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO | May 21, 1984 | Substantially Equivalent |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Mar 30, 1984 | Substantially Equivalent |
| K832126 | MICRO Z DISPOS. SPINAL ANESTH. NEEDLE | Aug 12, 1983 | Substantially Equivalent |
| K831765 | HERAPIN LOCK FLUSH SOLUTION USE KIT | Jul 12, 1983 | Substantially Equivalent |
| K830524 | HENKE JECT PRESSURE SYRINGE | Mar 24, 1983 | Substantially Equivalent |
| K830242 | MICRO 2 HYPODERMIC NEEDLES | Feb 15, 1983 | Substantially Equivalent |
| K761206 | INTEROSSEOUS NEEDLE | Dec 13, 1976 | Substantially Equivalent |