Impact Air 45 Handpiece for Periodontal Use

Q: What is the product code of K972376?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.

FDA 510(k) K972376 · Glenwood, LLC

Substantially Equivalent

510(k) numberK972376

Submission

Device name: Impact Air 45 Handpiece for Periodontal Use
Applicant: Glenwood, LLC
Tenafly, NJ, US
Received: June 25, 1997
Decision date: September 10, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EFB – Handpiece, Air-Powered, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4200
Specialty: Dental

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More from Ttbio Corp.

510(k)	Device	Decision
K972375	Impact Air 45 Handpiece for Endodontic UseEFB · Traditional	09/10/1997SE

Questions and answers

When was Impact Air 45 Handpiece for Periodontal Use cleared by the FDA?

Impact Air 45 Handpiece for Periodontal Use (K972376) received a 510(k) decision of Substantially Equivalent on September 10, 1997, 77 days after the submission was received.

What is the product code of K972376?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.