Cleared Traditional

HYGIENIC ANCHORINGS

K780804 · Hygienic Dental Mfg., Co., The · Dental
Jun 1978
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K780804 is an FDA 510(k) clearance for the HYGIENIC ANCHORINGS, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by Hygienic Dental Mfg., Co., The (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978, 34 days after receiving the submission on May 11, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K780804 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1978
Decision Date June 14, 1978
Days to Decision 34 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ECI — Band, Elastic, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410

Similar Devices — ECI Band, Elastic, Orthodontic

All 24
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · Ortho Kinetics Corp. · Apr 1998
GLENROE CHAIN
K980053 · Glenroe Technologies · Feb 1998
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495 · Glenroe · Dec 1997
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
K943419 · Jon-Ko Products, Inc. · May 1995
ORTHODONTIC ELASTOMERIC TUBE/THREAD
K943417 · Jon-Ko Products, Inc. · May 1995
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
K943418 · Jon-Ko Products, Inc. · May 1995