FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNION BROACH BLEACHING LIGHT
K Number: K895174
·
Decision Apr 13, 1990
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
11
Applicant Total
14
Review Days
249
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Basic Information
- Device Name
- UNION BROACH BLEACHING LIGHT
- K Number
- K895174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
- Date Received
- August 7, 1989
- Decision Date
- April 13, 1990
- Product Code
- EEG
- 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 |
|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | FDA class 1 | Dental |
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Other Clearances by Union Broach, Div. Moyco Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962733 | CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) | Oct 11, 1996 | Substantially Equivalent |
| K950365 | MOYCO-EDTA | Apr 27, 1995 | Substantially Equivalent |
| K941574 | RETRO MIRROR | May 18, 1994 | Substantially Equivalent |
| K940260 | THERMAL PULP TESTER | Mar 7, 1994 | Substantially Equivalent |
| K935542 | NICKEL-TITANIUM K-TYPE FILE | Jan 3, 1994 | Substantially Equivalent |
| K931742 | INJECT-R FILL | May 27, 1993 | Substantially Equivalent |
| K923661 | QUADRASORB FILTER | Oct 20, 1992 | Substantially Equivalent |
| K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | Mar 6, 1986 | Substantially Equivalent |
| K852474 | UNION BROACH BLEACHING LIGHT | Jul 1, 1985 | Substantially Equivalent |
| K823489 | ENDODONTIC BROACH-BARBED BROACH | Dec 15, 1982 | Substantially Equivalent |