FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRILL, DENTAL
K Number: K801887
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
12
Applicant Total
13
Review Days
23
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Basic Information
- Device Name
- DRILL, DENTAL
- K Number
- K801887
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4130
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Aesculap Instruments Corp.
- Date Received
- July 28, 1980
- Decision Date
- August 20, 1980
- Product Code
- DZA
- 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 |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | FDA class 1 | Dental |
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Other Clearances by Aesculap Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K885046 | INSITUCAT VALVE STRIPPER | Feb 28, 1990 | Substantially Equivalent |
| K890182 | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV | Feb 28, 1990 | Substantially Equivalent |
| K890443 | CASPAR SCALP CLIP, APPLIER | Jun 15, 1989 | Substantially Equivalent |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Jun 1, 1989 | Substantially Equivalent |
| K884057 | ELAN-E DISPOSABLE DRAPE | Oct 19, 1988 | Substantially Equivalent |
| K880704 | CERULLO SUCTION REGULATOR | Mar 29, 1988 | Substantially Equivalent |
| K860016 | AESCULAP BONE MILL | Mar 19, 1986 | Substantially Equivalent |
| K801888 | HANDPIECE, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K801886 | BURR, DENTAL | Aug 20, 1980 | Substantially Equivalent |
| K792558 | CONTAINER SYSTEM | Dec 27, 1979 | Substantially Equivalent |