FDA.reportPublic FDA data

PROCEM

Primary DI
M737P97021
Brand
PROCEM
Company
Ototronix, LLC
Model
P9702
Device description
Procem Cement
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEACement, Ear, Nose And Throat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEACement, Ear, Nose And ThroatDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140644000PROCEMOtotronix, LLC2014-06-19NEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M737P97021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
833067478
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M737M31101MAXUMM31102022-03-29
M737M31991MAXUMM31992022-03-29
M737M53031MAXUMM53032022-03-29
M7379860011PROCEM986-001986-0012020-12-02
M7379860021PROCEM986-002986-0022020-12-02
M7379860031PROCEM986-003986-0032020-12-02
M7379860041PROCEM986-004986-0042020-12-02
M737P97201PROCEMP97202020-12-02
M737P97301PROCEMP97302020-12-02
M737P97401PROCEMP97402020-12-02
M737G50001OtogramG50002016-09-13
M737G55001OtogramG55002016-09-13
M737M210L1MAXUMM210L2014-09-03
M737M210R1MAXUMM210R2014-09-03
M737M220L1MAXUMM220L2014-09-03
M737M220R1MAXUMM220R2014-09-03
M737M31001MAXUMM31002014-09-03
M737M410L1MAXUMM410L2014-09-03
M737M410R1MAXUMM410R2014-09-03
M737M420L1MAXUMM420L2014-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7379860011PROCEMOtotronix, LLCNEA2020-12-02
M7379860021PROCEMOtotronix, LLCNEA2020-12-02
M7379860031PROCEMOtotronix, LLCNEA2020-12-02
M7379860041PROCEMOtotronix, LLCNEA2020-12-02
M737P97201PROCEMOtotronix, LLCNEA2020-12-02
M737P97301PROCEMOtotronix, LLCNEA2020-12-02
M737P97401PROCEMOtotronix, LLCNEA2020-12-02
00888233025201N/ABIOMET MICROFIXATION, INCNEA2020-06-26
00841036141943OTOMIMIXBIOMET MICROFIXATION, INCNEA2015-09-11
00812282020375EnvoyCem®Envoy Medical CorporationNEA2014-09-24