FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURING LIGHT COVER
K Number: K884222
·
Decision Mar 17, 1989
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
5
Review Days
162
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Basic Information
- Device Name
- CURING LIGHT COVER
- K Number
- K884222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Steri-Shield Products, Inc.
- Date Received
- October 6, 1988
- Decision Date
- March 17, 1989
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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Other Clearances by Steri-Shield Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884223 | DENTAL LAMP HANDLE COVER | Mar 17, 1989 | Substantially Equivalent |
| K884220 | AIR WATER SYRINGE TIP SHIELD | Mar 17, 1989 | Substantially Equivalent |
| K884219 | BRACKET TABLE ARM COVER | Mar 17, 1989 | Substantially Equivalent |
| K884221 | ULTRASONIC SCALER COVER | Mar 17, 1989 | Substantially Equivalent |