FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR-ISOCETTE
K Number: K811665
·
Decision Jul 15, 1981
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
1
Applicant Total
24
Review Days
30
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Basic Information
- Device Name
- SR-ISOCETTE
- K Number
- K811665
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3910
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- J. Aderer, Inc.
- Date Received
- June 15, 1981
- Decision Date
- July 15, 1981
- Product Code
- ELK
- 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 |
|---|---|---|---|
| ELK | Teeth, Artificial, Backing And Facing | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELK), ordered by most recent decision date.
View allOther 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 |