FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIAMOND BURS-HANDPIECE
K Number: K854691
·
Decision Mar 25, 1986
Classifications
1
FEI Numbers
264
Registration Numbers
264
Same Product Code
26
Applicant Total
21
Review Days
124
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Basic Information
- Device Name
- DIAMOND BURS-HANDPIECE
- K Number
- K854691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3240
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- November 21, 1985
- Decision Date
- March 25, 1986
- Product Code
- EJL
- 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 |
|---|---|---|---|
| EJL | Bur, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
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MONOSTERYL
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DENTAL OR SURGICAL BUR
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Other Clearances by Almore Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862851 | ALMORE FACE MASK | Aug 12, 1986 | Substantially Equivalent |
| K854692 | MONARCH II BLEACHING INSTRUMENT | May 12, 1986 | Substantially Equivalent |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Mar 25, 1986 | Substantially Equivalent |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | Mar 12, 1986 | Substantially Equivalent |
| K854702 | PLASTIC MOUNTING RINGS | Mar 6, 1986 | Substantially Equivalent |
| K854701 | RETRACT-A-CORD | Mar 6, 1986 | Substantially Equivalent |
| K854697 | TUBING HANDPIECE REPLACEMENT | Mar 6, 1986 | Substantially Equivalent |
| K854699 | TUBING SYRING | Jan 6, 1986 | Substantially Equivalent |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Jun 8, 1983 | Substantially Equivalent |