FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUSTENAL ACUSOFT SOFT LINER
K Number: K862557
·
Decision Feb 19, 1987
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
19
Review Days
231
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Basic Information
- Device Name
- AUSTENAL ACUSOFT SOFT LINER
- K Number
- K862557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Austenal Dental, Inc.
- Date Received
- July 3, 1986
- Decision Date
- February 19, 1987
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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Other Clearances by Austenal Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890713 | OVERDENTURE - STUD ATTACHMENT | Jul 14, 1989 | Substantially Equivalent |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | Oct 20, 1988 | Substantially Equivalent |
| K880875 | VITALLIUM EQUIPOISE ALLOY | Apr 7, 1988 | Substantially Equivalent |
| K871849 | LIGHT CURE DENTURE GLAZE | Aug 10, 1987 | Substantially Equivalent |
| K872746 | VITALLIUM WIRE | Jul 21, 1987 | Substantially Equivalent |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | Mar 11, 1987 | Substantially Equivalent |
| K865025 | AUSTENAL CONDENSING INSTRUMENT | Feb 19, 1987 | Substantially Equivalent |
| K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | Feb 10, 1987 | Substantially Equivalent |
| K862856 | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR | Aug 26, 1986 | Substantially Equivalent |
| K862667 | COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY | Jul 31, 1986 | Substantially Equivalent |