FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K Number: K833304
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
15
Applicant Total
9
Review Days
189
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
- HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
- K Number
- K833304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4730
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew, Mpl Division
- Date Received
- September 23, 1983
- Decision Date
- March 30, 1984
- Product Code
- DZM
- 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 |
|---|---|---|---|
| DZM | Needle, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZM), ordered by most recent decision date.
X-TIP INTRAOSSEOUS PERFORATOR
FDA 510(k)
FDA Class 1
·Dental
JENKER NEEDLE STICK PROTECTOR
FDA 510(k)
FDA Class 1
·Dental
ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SAFETY PLUS DENTAL INJECTION NEEDLE
FDA 510(k)
FDA Class 1
·Dental
DENTAL NEEDLE PROTECTIVE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
STABIDENT LOCAL ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 1
·Dental
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 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Apr 5, 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 |