FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUSTRALLOY
K Number: K820738
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- LUSTRALLOY
- K Number
- K820738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Hoyt Laboratories
- Date Received
- March 18, 1982
- Decision Date
- April 9, 1982
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
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Other Clearances by Hoyt Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K811154 | HOYT ECONO-TRAY | May 13, 1981 | Substantially Equivalent |
| K810830 | HOYT COTTON ROLLS | Apr 14, 1981 | Substantially Equivalent |
| K780834 | PREVI DENT PROPHYLAXIS MINT NDC | Jun 2, 1978 | Substantially Equivalent |
| K771881 | REPLICA BONDING AGENT | Nov 9, 1977 | Substantially Equivalent |
| K771880 | REPLICA DENTAL COMPOSIT | Oct 20, 1977 | Substantially Equivalent |
| K771883 | REPLICA ACID-ETCH | Oct 20, 1977 | Substantially Equivalent |
| K771882 | REPLICA DENTAL COMPOSITE-RADIOPAQUE | Oct 20, 1977 | Substantially Equivalent |
| K771185 | PERIODONTIC TOOTHBRUSH, #0126-0190-00 | Jul 15, 1977 | Substantially Equivalent |
| K771184 | TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 | Jul 15, 1977 | Substantially Equivalent |
| K771183 | TOOTHBRUSH, PEDODONTIC, #0126-0188-00 | Jul 15, 1977 | Substantially Equivalent |