FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
K Number: K980963
·
Decision May 11, 1998
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
14
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
- K Number
- K980963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Foremost Dental Mfg., Inc.
- Date Received
- March 16, 1998
- Decision Date
- May 11, 1998
- 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.
Dia-X Sil Bite
FDA 510(k)
FDA Class 2
·Dental
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
FDA 510(k)
FDA Class 2
·Dental
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
Other Clearances by Foremost Dental Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982201 | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | Aug 10, 1998 | Substantially Equivalent |
| K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | Jul 10, 1998 | Substantially Equivalent |
| K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | Jul 15, 1997 | Substantially Equivalent |
| K970774 | TEMPOCEM NE (MULTIPLE) | Jun 3, 1997 | Substantially Equivalent |
| K970775 | TEMPO CEM (MULTIPLE) | Jun 3, 1997 | Substantially Equivalent |
| K954867 | IONOSIT SEAL | Mar 8, 1996 | Substantially Equivalent |
| K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | Jan 18, 1994 | Substantially Equivalent |
| K890464 | ZENITH 40% PHOSPHORIC ACID GEL | Feb 13, 1989 | Substantially Equivalent |
| K871562 | IONOCAL | May 20, 1987 | Substantially Equivalent |
| K864898 | FOREMOST DENTIN ADHESIVE | Feb 12, 1987 | Substantially Equivalent |