FDA.reportPublic FDA data

510(k) K771451

Device
SCUTABOND
Applicant
Premier Dental Products Co.
510(k) number
K771451
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-16
Date received
1977-08-03
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
N

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 EMA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254109G-CEM UNIVERSALGC America, Inc.2026-05-18
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K252165ZIRCONOMER PShofu Dental Corporation2025-10-28
K250953EQUIA LC ONEGC America, Inc.2025-09-19
K251775RODIN CementBelport Company, Inc., Gingi-Pak2025-09-02
K251470ResiCem EXShofu Dental Corporation2025-07-11
K250156Choice 2 DCBisco, Inc.2025-07-11
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K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.2025-01-10
K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd.2024-06-28