FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPIRIT II AND SPIRIT TREATMENT CENTER
K Number: K946187
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
281
Applicant Total
14
Review Days
71
Basic Information
- Device Name
- SPIRIT II AND SPIRIT TREATMENT CENTER
- K Number
- K946187
- 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
- December 20, 1994
- Decision Date
- March 1, 1995
- 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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|---|---|---|---|
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| K945117 | DELTA | Feb 28, 1997 | Substantially Equivalent |
| K962071 | SPIRIT S1/S2 | Aug 6, 1996 | Substantially Equivalent |
| K960819 | HELIODENT DS | Mar 29, 1996 | Substantially Equivalent |
| K950299 | CEREC 2 | May 23, 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 |