FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DURACLEAN DENTURE CLEANER
K Number: K852906
·
Decision Jul 31, 1985
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
13
Applicant Total
5
Review Days
22
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Basic Information
- Device Name
- DURACLEAN DENTURE CLEANER
- K Number
- K852906
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3530
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Astron Dental Corp.
- Date Received
- July 9, 1985
- Decision Date
- July 31, 1985
- Product Code
- JER
- 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 |
|---|---|---|---|
| JER | Cleaner, Denture, Mechanical | FDA class 1 | Dental |
Similar 510(k) Clearances
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Other Clearances by Astron Dental Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Dec 23, 1987 | Substantially Equivalent |
| K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Feb 10, 1987 | Substantially Equivalent |
| K833270 | ASTRON 77 INJECTION DENTURE RESIN | Jul 19, 1984 | Substantially Equivalent |
| K831269 | VINYLAC PRESS-PACK DENTURE RESIN | Jun 8, 1983 | Substantially Equivalent |