Dental Lamp Handle Cover

FDA 510(k) K884223 · Steri-Shield Products, Inc.

Substantially Equivalent

510(k) numberK884223

Submission

Device name
Dental Lamp Handle Cover
Applicant
Steri-Shield Products, Inc.
Allentown, PA, US
Received
October 6, 1988
Decision date
March 17, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EAZ – Light, Operating, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4630
Specialty
Dental

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More from Micronaire Corp.

510(k)DeviceDecision
K884222Curing Light CoverEBZ · Traditional 03/17/1989SE
K884221Ultrasonic Scaler CoverELC · Traditional 03/17/1989SE
K884220Air Water Syringe Tip ShieldEFS · Traditional 03/17/1989SE
K884219Bracket Table Arm CoverEIA · Traditional 03/17/1989SE

Questions and answers

When was Dental Lamp Handle Cover cleared by the FDA?

Dental Lamp Handle Cover (K884223) received a 510(k) decision of Substantially Equivalent on March 17, 1989, 162 days after the submission was received.

What is the product code of K884223?

The FDA product code is EAZ – Light, Operating, Dental, a Class I (low risk) device regulated under 21 CFR 872.4630.