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510(k) K832366

Device
ZOLLER BURNED LIP CONFORMER
Applicant
UNIVERSAL PROSTHETICS, INC.
510(k) number
K832366
Product code
EIG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-26
Date received
1983-07-18
Regulation
872.4565
Classification name
Retractor, All Types
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 EIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971284OPALDAMUltradent Products, Inc.1997-06-03
K854711FIBRELIGHT ILLUMINATING ORAL RETRACTORSDowns Surgical , Ltd.1986-02-25
K821784BEACH GINGIVAL RETRACTION INSTR. TYPE BPacific Dental Corp.1982-07-06
K771973GINGITRACTDen-Mat Corp.1977-11-07
K771399LIP & CHEEK RETRACTORL.D. Caulk Co.1977-08-26
K761024RACESTYPTINE RINGSSeptodont, Inc.1976-11-19
K760657RACESTYPTINE CORDSeptodont, Inc.1976-09-27

Legacy Summary#

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FDA Review#

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