Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02

FDA 510(k) K070127 · Kevin Vu, Dds

Substantially Equivalent

510(k) numberK070127

Submission

Device name
Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02
Applicant
Kevin Vu, Dds
San Diego, CA, US
Received
January 16, 2007
Decision date
March 29, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EMN – Scaler, Periodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EMN

510(k)DeviceApplicantDecision
K931330Dental Instruments ScalerEMN · Traditional Minnesota Prophy Power, Inc.01/26/1994SE
K8517211200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional Artiberia07/02/1985SE
K821786Beach ScalersEMN · Traditional Pacific Dental Corp.07/06/1982SE
K781035Periodontal Instrument #21 Goldman-FoxEMN · Traditional Premier Dental Products Co.06/30/1978SE

Questions and answers

When was Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02 cleared by the FDA?

Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02 (K070127) received a 510(k) decision of Substantially Equivalent on March 29, 2007, 72 days after the submission was received.

What is the product code of K070127?

The FDA product code is EMN – Scaler, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.