FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOUBLE BOW TOOTH SEPARATOR
K Number: K831136
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
2
Applicant Total
21
Review Days
62
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Basic Information
- Device Name
- DOUBLE BOW TOOTH SEPARATOR
- K Number
- K831136
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- April 7, 1983
- Decision Date
- June 8, 1983
- Product Code
- JEP
- 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 |
|---|---|---|---|
| JEP | Retainer, Matrix | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEP), ordered by most recent decision date.
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
FDA 510(k)
FDA Class 1
·Dental
OMNI-MATRIX
FDA 510(k)
FDA Class 1
·Dental
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 |