Hawley Retainer Orthodontic Applicance Kit

FDA 510(k) K943334 · Jay H. Geller

Substantially Equivalent

510(k) numberK943334

Submission

Device name
Hawley Retainer Orthodontic Applicance Kit
Applicant
Jay H. Geller
Santa Monica, CA, US
Received
July 12, 1994
Decision date
October 5, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DZC – Wire, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Specialty
Dental

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K933374Niti Coil SpringsDZC · Traditional Highland Metals11/19/1993SE
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K933380Reverse Surve Niti Arch WireDZC · Traditional Highland Metals11/12/1993SE
K933379Stainless Steel ArchesDZC · Traditional Highland Metals11/12/1993SE
K933378Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional Highland Metals11/12/1993SE

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Questions and answers

When was Hawley Retainer Orthodontic Applicance Kit cleared by the FDA?

Hawley Retainer Orthodontic Applicance Kit (K943334) received a 510(k) decision of Substantially Equivalent on October 5, 1994, 85 days after the submission was received.

What is the product code of K943334?

The FDA product code is DZC – Wire, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.