Titanium Bird Beak Plier

FDA 510(k) K955242 · Sybron Dental Specialties, Inc.

Substantially Equivalent

510(k) numberK955242

Submission

Device name
Titanium Bird Beak Plier
Applicant
Sybron Dental Specialties, Inc.
Glendora, CA, US
Received
November 15, 1995
Decision date
December 1, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JEX – Plier, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code JEX

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K935141Dentaurum PliersJEX · Traditional Dentauraum, Inc.01/31/1994SE
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K924295Debracketing InstrumentJEX · Traditional Unitek Corp.11/23/1992SE
K854088Unitek Lift-Off Debracketing InstrumentJEX · Traditional Unitex Corp.11/26/1985SE
K843742Unitek Convertible Cap Remover ToolJEX · Traditional Unitek Corp.11/09/1984SE
K760984Orthodontic InstrumentsJEX · Traditional Adp Intl., Inc.11/15/1976SE

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Questions and answers

When was Titanium Bird Beak Plier cleared by the FDA?

Titanium Bird Beak Plier (K955242) received a 510(k) decision of Substantially Equivalent on December 1, 1995, 16 days after the submission was received.

What is the product code of K955242?

The FDA product code is JEX – Plier, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.