FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CROWN, ACRYLIC, CORAL BRAND, PREFORMED
K Number: K770684
·
Decision Apr 26, 1977
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
8
Applicant Total
30
Review Days
14
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Basic Information
- Device Name
- CROWN, ACRYLIC, CORAL BRAND, PREFORMED
- K Number
- K770684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3330
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- April 12, 1977
- Decision Date
- April 26, 1977
- Product Code
- ELZ
- 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 |
|---|---|---|---|
| ELZ | Crown, Preformed | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELZ), ordered by most recent decision date.
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SDI POLYCARBONATE CROWN, SCHEIN'S
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Other Clearances by Parker Laboratories, Inc.
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|---|---|---|---|
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| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent |
| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | Aug 9, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |