Spirit II and Spirit Treatment Center
FDA 510(k) K946187 · Pelton & Crane Co.
510(k) numberK946187
Submission
- Device name
- Spirit II and Spirit Treatment Center
- Applicant
- Pelton & Crane Co.
Charlotte, NC, US - Received
- December 20, 1994
- Decision date
- March 1, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Megagen Implant Co., Ltd.
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|---|---|---|
| K171872 | P50 Series Dental Operative Unit and AccessoriesEIA · Traditional | 04/26/2018SE |
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| K972249 | Orthophos Plus and Orthophos Plus/CdEHD · Traditional | 09/12/1997SE |
| K972168 | Sidexis Digital Radiography SystemEHD · Traditional | 09/05/1997SE |
| K945117 | DeltaFLE · Traditional | 02/28/1997SE |
| K962071 | Spirit S1/S2EIA · Traditional | 08/06/1996SE |
| K960819 | Heliodent DSEAP · Traditional | 03/29/1996SE |
| K950299 | Cerec 2ELW · Traditional | 05/23/1995SE |
| K950030 | Heliodent MDEAP · Traditional | 02/03/1995SE |
| K936068 | Orthophos 3/ Orthophos 3CEAP · Traditional | 07/29/1994SE |
Questions and answers
When was Spirit II and Spirit Treatment Center cleared by the FDA?
Spirit II and Spirit Treatment Center (K946187) received a 510(k) decision of Substantially Equivalent on March 1, 1995, 71 days after the submission was received.
What is the product code of K946187?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.