FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEREC 2
K Number: K950299
·
Decision May 23, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
14
Review Days
118
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
- CEREC 2
- K Number
- K950299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pelton & Crane Co.
- Date Received
- January 25, 1995
- Decision Date
- May 23, 1995
- 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 Pelton & Crane Co.
| K Number | Device Name | ||
|---|---|---|---|
| K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | Sep 12, 1997 | Substantially Equivalent |
| K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | Sep 5, 1997 | Substantially Equivalent |
| K945117 | DELTA | Feb 28, 1997 | Substantially Equivalent |
| K962071 | SPIRIT S1/S2 | Aug 6, 1996 | Substantially Equivalent |
| K960819 | HELIODENT DS | Mar 29, 1996 | Substantially Equivalent |
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | Mar 1, 1995 | Substantially Equivalent |
| K950030 | HELIODENT MD | Feb 3, 1995 | Substantially Equivalent |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Jul 29, 1994 | Substantially Equivalent |
| K935390 | SIROLUX FANTASTIC | Dec 10, 1993 | Substantially Equivalent |
| K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT | Jul 6, 1990 | Substantially Equivalent |