FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
K Number: K925629
·
Decision Nov 23, 1993
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
22
Applicant Total
7
Review Days
382
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Basic Information
- Device Name
- ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
- K Number
- K925629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Den-Tal-Ez Mfg Co., Inc.
- Date Received
- November 6, 1992
- Decision Date
- November 23, 1993
- Product Code
- EAZ
- 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 |
|---|---|---|---|
| EAZ | Light, Operating, Dental | FDA class 1 | Dental |
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Other Clearances by Den-Tal-Ez Mfg Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932824 | EVACUATOR, ORAL CAVITY | Sep 28, 1993 | Substantially Equivalent |
| K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | Jul 8, 1993 | Substantially Equivalent |
| K920017 | IMPROVED DENTAL OPERATING LIGHT | Mar 2, 1992 | Substantially Equivalent |
| K920016 | IMPROVED DENTAL CHAIR | Mar 2, 1992 | Substantially Equivalent |
| K874294 | AUTOCHUCK ATTACHMENT | Dec 29, 1987 | Substantially Equivalent |
| K780469 | PANORAMIC X-RAY, DENTAL | Apr 10, 1978 | Substantially Equivalent |