Shield

FDA 510(k) K780263 · Lorvic Corp.

Substantially Equivalent

510(k) numberK780263

Submission

Device name
Shield
Applicant
Lorvic Corp.
Mchenry, IL, US
Received
February 17, 1978
Decision date
May 3, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJK – Liner, Cavity, Calcium Hydroxide
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3250
Specialty
Dental

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K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional Prevest Denpro Limited05/13/2022SE
K201799CleaniCalEJK · Traditional Maruchi02/12/2021SE
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K191103Parkell Desensitizer GelEJK · Traditional Parkell, Inc.11/22/2019SE
K180344TheraCal DCEJK · Special Bisco, Inc.04/05/2018SE
K143292TheraCal DCEJK · Traditional Bisco, Inc.08/04/2015SE
K150559Life Fast Set, Life Regular SetEJK · Special Sybron Dental Specialties06/19/2015SE

More from Sybron Dental Specialties

510(k)DeviceDecision
K871615U. V. Germicidal UnitKMH · Traditional 09/11/1987SE
K770064Fluoride Gel Disposable TrayKMT · Traditional 01/14/1977SE
K770063Disp. Absorbent Compressed Fibre WaferEFN · Traditional 01/14/1977SE
K760620Saliva EjectorDYN · Traditional 09/21/1976SE
K760121Impulse Heat Sealer · Traditional 07/16/1976SE

Questions and answers

When was Shield cleared by the FDA?

Shield (K780263) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 75 days after the submission was received.

What is the product code of K780263?

The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.