FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
K Number: K052409
·
Decision Oct 20, 2005
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
399
Applicant Total
11
Review Days
49
Basic Information
- Device Name
- SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
- K Number
- K052409
- 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
- September 1, 2005
- Decision Date
- October 20, 2005
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELW), ordered by most recent decision date.
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
FDA 510(k)
FDA Class 2
·Dental
Elastic Impression Material
FDA 510(k)
FDA Class 2
·Dental
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
FDA 510(k)
FDA Class 2
·Dental
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
FDA 510(k)
FDA Class 2
·Dental
DentMix VPS Impression Material
FDA 510(k)
FDA Class 2
·Dental
No Stress Impress
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by SULTAN CHEMISTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM | Nov 16, 2005 | Substantially Equivalent |
| K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | Feb 18, 2005 | Substantially Equivalent |
| K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | Apr 9, 2003 | Substantially Equivalent |
| K020612 | SULTAN SPOROX TEST VIAL, MODEL 75195 | May 7, 2002 | Substantially Equivalent |
| K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | Nov 15, 2000 | Substantially Equivalent |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | Jul 14, 1999 | Substantially Equivalent |
| 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 |