FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
K Number: K030414
·
Decision Apr 9, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
- K Number
- K030414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sultan Chemists, Inc.
- Date Received
- February 7, 2003
- Decision Date
- April 9, 2003
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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| K971138 | DINABASE (TM) | Jul 21, 1997 | Substantially Equivalent |
| K951590 | ASSURE, SELF-SEALING STERILIZATION POUCH | May 17, 1995 | Substantially Equivalent |
| K933729 | ASSURE SELF SEALING STERILIZATION POUCH | Jun 21, 1994 | Substantially Equivalent |
| K896826 | SULTAN PERIO-SELECT IRRIGATION SYSTEM | Mar 2, 1990 | Unknown |