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510(k) K801548

Device
Perf-lock Impression Tray
Applicant
DENTSPLY INTL.
510(k) number
K801548
Product code
EHY
Decision
Substantially Equivalent (SESE)
Decision date
1980-07-21
Date received
1980-07-07
Regulation
872.6880
Classification name
Tray, Impression, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942668O-TRAY IMPRESSION TRAYSDentauraum, Inc.1994-07-22
K896470EOS IMPRESSION TRAYSIvoclar North America, Inc.1990-02-09
K884316OCCLUSAL HARMONY IMPRESSION TRAYAdvantage Dental Co.1988-12-22
K863836POST TRAYMarket Masters, Inc.1986-10-14
K850776PREFORMED DENTAL IMPRESSION TRAYSL.A.K. Ent., Inc.1985-03-18
K842273CROWN INDEX TRAYDi-Equi Dental Products1984-07-31
K842274F-G-P TRAYDi-Equi Dental Products1984-07-31
K841491CONVENTIONAL PLASTIC DENTAL TRAYSBuffalo Dental Mfg. Co., Inc.1984-07-13
K841323FUZZY TRAYBuffalo Dental Mfg. Co., Inc.1984-06-27
K833485IMPRESSION TUBE ADJUSTABLEZefr, Inc.1983-12-26
K810524SR-IVOTRAY SPECIALJ. Aderer, Inc.1981-03-17
K810525SR-IVOTRAY UNIVERSALJ. Aderer, Inc.1981-03-17
K800900PREMIER TRIPLE TRAYPremier Dental Products Co.1980-04-29
K780678IMPRESSION TRAYRocky Mountain Orthodontics, Inc.1978-04-28
K7802114-IN-1 DISP. CROWN & BRIDGE TRAYKerr Corporation (Danbury)1978-02-16