FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCHEIN BLEACHING UNIT
K Number: K862385
·
Decision Oct 30, 1986
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
11
Applicant Total
8
Review Days
128
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Basic Information
- Device Name
- SCHEIN BLEACHING UNIT
- K Number
- K862385
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Henry Schein, Inc.
- Date Received
- June 24, 1986
- Decision Date
- October 30, 1986
- 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 Henry Schein, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041580 | IMAGERAYI | Jun 29, 2004 | Substantially Equivalent |
| K862384 | SCHEIN AP-1 AIR POLISHING UNIT | Nov 7, 1986 | Substantially Equivalent |
| K841199 | FIBERGLASS MOUTH MIRRORS | Apr 25, 1984 | Substantially Equivalent |
| K834055 | VANADIUM EXCAVATORS SIZES 0-6 | Feb 21, 1984 | Substantially Equivalent |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | Feb 3, 1984 | Substantially Equivalent |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | May 20, 1980 | Substantially Equivalent |
| K781592 | SURGICAL ASPIRATOR TIPS | Dec 4, 1978 | Substantially Equivalent |