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510(k) K811889

Device
R & S SERIES FITTING TOOLS
Applicant
SUNCOAST DENTAL CORP.
510(k) number
K811889
Product code
EIC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-24
Date received
1981-07-01
Regulation
872.4565
Classification name
Syringe, Periodontic, Endodontic, Irrigating
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972234RCT GEL ROOT CANAL THERAPY GELDentsply Intl.1997-06-30
K864307MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)Smith & Nephew, Inc.1986-11-18
K861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITSolar Dental Co., Inc.1986-06-26
K851944MAX-I-PROBE HANDPIECESolo Pak Laboratories1985-07-01
K840237MAX-I-PROBE PERIODONTAL ENDODONTIC PROBSmith & Nephew, Mpl Division1984-04-05
K811594WATER PISTOLAus-Tex Dental Mfg. & Design1981-07-15
K801483MARK IV SYRINGENational Patent Development Corp.1980-07-21
K801484ROOT CANAL FILLING APPLICATOR NEEDLESNational Patent Development Corp.1980-07-21
K792577ENDOVAGE SYRINGEDental Development Services, Inc.1980-01-04
K792578EPIC CANNULADental Development Services, Inc.1980-01-04
K792461CENTRIX MKIV ENDODONTIC DELIVERYCentrix, Inc.1979-12-19
K771406GUTTA GUNAus-Tex Dental Mfg. & Design1977-08-26
K770967SYRINGE, ENDODONTIC, W/PERFORATED NEEDLENational Patent Development Corp.1977-06-20
K770813ENDOGATORAus-Tex Dental Mfg. & Design1977-05-20
K770642SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLENational Patent Development Corp.1977-04-15

Legacy Summary#

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FDA Review#

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