Bari-Kad Packing Device

FDA 510(k) K050318 · Bioenvelop Agro, Inc.

Substantially Equivalent

510(k) numberK050318

Submission

Device name
Bari-Kad Packing Device
Applicant
Bioenvelop Agro, Inc.
West Cadwell, NJ, US
Received
February 9, 2005
Decision date
March 4, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EIE – Dam, Rubber
Device class
Class I (low risk)
Regulation
21 CFR 872.6300
Specialty
Dental

Other 510(k)s with product code EIE

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K182118armor LCEIE · Traditional Mavrik Dental Systems, Ltd.05/03/2019SE
K151945Triumph Resin DamEIE · Traditional Denali Corporation02/18/2016SE
K043301GC Tion Gingival ProtectorEIE · Traditional GC America, Inc.01/25/2005SE
K040797Britesmile Masking CreamEIE · Special Britesmile, Inc.04/02/2004SE
K022522Pulpdent Putty DamEIE · Traditional Pulpdent Corporation09/26/2002SE
K021524Light Cure Dental DamEIE · Traditional Prime Dental Manufacturing, Inc.07/19/2002SE
K021613Niveous Liquid DamEIE · Traditional Shofu Dental Corp.06/20/2002SE
K010935Britesmile Barrier MaterialEIE · Traditional Britesmile, Inc.09/05/2001SE
K983227Power BlockEIE · Traditional Kreativ, Inc.12/11/1998SE
K972775FastdamEIE · Traditional Interdent, Inc.02/27/1998SE

Questions and answers

When was Bari-Kad Packing Device cleared by the FDA?

Bari-Kad Packing Device (K050318) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 23 days after the submission was received.

What is the product code of K050318?

The FDA product code is EIE – Dam, Rubber, a Class I (low risk) device regulated under 21 CFR 872.6300.