FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BALANCE ARTICULATOR
K Number: K811075
·
Decision May 13, 1981
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
10
Applicant Total
21
Review Days
23
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Basic Information
- Device Name
- BALANCE ARTICULATOR
- K Number
- K811075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3150
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- April 20, 1981
- Decision Date
- May 13, 1981
- Product Code
- EJP
- 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 |
|---|---|---|---|
| EJP | Articulators | FDA class 1 | Dental |
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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 |
| K854691 | DIAMOND BURS-HANDPIECE | 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 |