FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
K Number: K770967
·
Decision Jun 20, 1977
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
15
Applicant Total
34
Review Days
20
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Basic Information
- Device Name
- SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
- K Number
- K770967
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- National Patent Development Corp.
- Date Received
- May 31, 1977
- Decision Date
- June 20, 1977
- 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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|---|---|---|---|
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| K822793 | PIO ROOT CANAL INDICATOR | Oct 22, 1982 | Substantially Equivalent |
| K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS | Mar 11, 1982 | Substantially Equivalent |
| K820006 | ZEON COMPOSITE RESIN SYSTEM | Jan 22, 1982 | Substantially Equivalent |
| K811446 | HYDRON WOUND DRESSING KIT | Jun 12, 1981 | Substantially Equivalent |
| K801483 | MARK IV SYRINGE | Jul 21, 1980 | Substantially Equivalent |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | Jul 21, 1980 | Substantially Equivalent |
| K801482 | HYDRON ROOT CANAL FILLING MATERIAL | Jul 21, 1980 | Substantially Equivalent |
| K792136 | HYPO-ALLERGENIC PLASTIC TAPE | Jan 16, 1980 | Substantially Equivalent |