FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLUNT TIP IRRIGATION NEEDLES
K Number: K921354
·
Decision Sep 25, 1992
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
6
Review Days
189
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Basic Information
- Device Name
- BLUNT TIP IRRIGATION NEEDLES
- K Number
- K921354
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovators, Inc.
- Date Received
- March 20, 1992
- Decision Date
- September 25, 1992
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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Other Clearances by Innovators, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921355 | WINGMASTER | Sep 25, 1992 | Substantially Equivalent |
| K921406 | SILICONT BUR BLOCK | Apr 28, 1992 | Substantially Equivalent |
| K844351 | OPTI-LITE | Dec 21, 1984 | Substantially Equivalent |
| K830042 | E-Z JECTOR | Jan 26, 1983 | Substantially Equivalent |
| K790984 | KLIP-LITE | Oct 22, 1979 | Substantially Equivalent |