Novel Dispenser/Package

FDA 510(k) K833955 · Dentsply Intl.

Substantially Equivalent

510(k) numberK833955

Submission

Device name
Novel Dispenser/Package
Applicant
Dentsply Intl.
Mchenry, IL, US
Received
November 16, 1983
Decision date
January 3, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EIY – Instrument, Filling, Plastic, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EIY

510(k)DeviceApplicantDecision
K871909Composite Restorative CarrierEIY · Traditional Dentsply Intl.05/27/1987SE
K8517261760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional Artiberia07/02/1985SE
K830776Microfil Contouring InstrumentsEIY · Traditional Almore Intl., Inc.04/28/1983SE
K823323Dental Instruments - Plastic InstrumentsEIY · Traditional Miltex, Inc.11/24/1982SE

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K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional 03/27/2008SE
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Questions and answers

When was Novel Dispenser/Package cleared by the FDA?

Novel Dispenser/Package (K833955) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 48 days after the submission was received.

What is the product code of K833955?

The FDA product code is EIY – Instrument, Filling, Plastic, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.