FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR-IVOLEN
K Number: K810686
·
Decision Apr 14, 1981
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
24
Review Days
32
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Basic Information
- Device Name
- SR-IVOLEN
- K Number
- K810686
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3670
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- J. Aderer, Inc.
- Date Received
- March 13, 1981
- Decision Date
- April 14, 1981
- Product Code
- EBH
- 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 |
|---|---|---|---|
| EBH | Material, Impression Tray, Resin | FDA class 1 | Dental |
Similar 510(k) Clearances
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POLYESTER RESIN HAND MOLDED TRAY
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PALAVIT L
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Other Clearances by J. Aderer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822956 | G CAST | Oct 26, 1982 | Substantially Equivalent |
| K822957 | PURCAST | Oct 26, 1982 | Substantially Equivalent |
| K821798 | 82 ALLOY | Jul 13, 1982 | Substantially Equivalent |
| K821832 | DEGUCAST U | Jul 6, 1982 | Substantially Equivalent |
| K821572 | DUALLOR 'R' | Jun 14, 1982 | Substantially Equivalent |
| K821590 | PORS-ON | Jun 14, 1982 | Substantially Equivalent |
| K821407 | DEVA M | Jun 9, 1982 | Substantially Equivalent |
| K821446 | DEGUDENT 14 | Jun 9, 1982 | Substantially Equivalent |
| K821521 | STABILOR NF | Jun 9, 1982 | Substantially Equivalent |
| K821613 | E.G. BRIDGE GOLD | Jun 4, 1982 | Substantially Equivalent |