FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPIRIT S1/S2
K Number: K962071
·
Decision Aug 6, 1996
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- SPIRIT S1/S2
- K Number
- K962071
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pelton & Crane Co.
- Date Received
- May 28, 1996
- Decision Date
- August 6, 1996
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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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 |
| K960819 | HELIODENT DS | Mar 29, 1996 | Substantially Equivalent |
| K950299 | CEREC 2 | May 23, 1995 | 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 |