Orthodontic Instruments

FDA 510(k) K760984 · Adp Intl., Inc.

Substantially Equivalent

510(k) numberK760984

Submission

Device name
Orthodontic Instruments
Applicant
Adp Intl., Inc.
Mchenry, IL, US
Received
October 21, 1976
Decision date
November 15, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
K955242Titanium Bird Beak PlierJEX · Traditional Sybron Dental Specialties, Inc.12/01/1995SE
K935141Dentaurum PliersJEX · Traditional Dentauraum, Inc.01/31/1994SE
K924645Transcend Series 6000 Debonding InstrumentsJEX · Traditional Unitek Corp.11/25/1992SE
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

More from Unitek Corp.

510(k)DeviceDecision
K760988Dental Handpieces · Traditional 11/15/1976SE
K760987Diamond StonesDZP · Traditional 11/15/1976SE
K760986Carbide Dental BursEJL · Traditional 11/15/1976SE
K760985Hand InstrumentsEKW · Traditional 11/15/1976SE
K760983Endodontic InstrumentsEKN · Traditional 11/15/1976SE
K760982Dental VarnishLBH · Traditional 11/15/1976SE
K760981Alginate Impression MaterialELW · Traditional 11/15/1976SE
K760980Dental AlloyEJJ · Traditional 11/15/1976SE
K760979Composite MaterialEBF · Traditional 11/15/1976SE
K760978Zinc CementEMA · Traditional 11/15/1976SE

Questions and answers

When was Orthodontic Instruments cleared by the FDA?

Orthodontic Instruments (K760984) received a 510(k) decision of Substantially Equivalent on November 15, 1976, 25 days after the submission was received.

What is the product code of K760984?

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