Spirit

FDA 510(k) K143696 · Pelton & Crane

Substantially Equivalent

510(k) numberK143696

Submission

Device name
Spirit
Applicant
Pelton & Crane
Charlotte, NC, US
Received
December 24, 2014
Decision date
September 18, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIA – Unit, Operative Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Specialty
Dental

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K242404BDC Dental UnitEIA · Traditional Bdc Dental Corporation , Ltd.02/07/2025SE
K231297Firstar Dental UnitEIA · Traditional Firstar Dental Company01/27/2025SE
K233805K5EIA · Traditional Osstem Implant Co., Ltd. Chair Business09/03/2024SE
K240754N2EIA · Special Megagen Implant Co., Ltd.03/21/2024SE

More from Megagen Implant Co., Ltd.

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K171872P50 Series Dental Operative Unit and AccessoriesEIA · Traditional 04/26/2018SE
K972249Orthophos Plus and Orthophos Plus/CdEHD · Traditional 09/12/1997SE
K972168Sidexis Digital Radiography SystemEHD · Traditional 09/05/1997SE
K945117DeltaFLE · Traditional 02/28/1997SE
K962071Spirit S1/S2EIA · Traditional 08/06/1996SE
K960819Heliodent DSEAP · Traditional 03/29/1996SE
K950299Cerec 2ELW · Traditional 05/23/1995SE
K946187Spirit II and Spirit Treatment CenterEIA · Traditional 03/01/1995SE
K950030Heliodent MDEAP · Traditional 02/03/1995SE
K936068Orthophos 3/ Orthophos 3CEAP · Traditional 07/29/1994SE

Questions and answers

When was Spirit cleared by the FDA?

Spirit (K143696) received a 510(k) decision of Substantially Equivalent on September 18, 2015, 268 days after the submission was received.

What is the product code of K143696?

The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.