FDA.reportPublic FDA data

PeriAcryl

Primary DI
D7950000041
Brand
PeriAcryl
Company
Glustich Inc
Model
P-ACRYLU(C)
Published
2017-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071484000PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc.2007-10-10EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7950000041PackageHIBCC12Not in Commercial Distribution
D7950000030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical periodontal dressingA dental material intended to be used during periodontal procedures to facilitate periodontal tissue healing by providing mechanical, chemical, and/or thermal protection to wounded tissue after surgery or disease, and/or by functioning as a barrier for the prevention of bacterial infiltration in a periodontal pocket after root surface debridement (RSD) and/or planing and root scaling. Some types may adhere to teeth and gums and be used to secure medications, temporary prostheses, and loose teeth. It is available in various forms (e.g., gel in a syringe, fluid in a dispenser with mixing nozzle, substance mixed chairside into a pliable paste). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201637158
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D795210GluSeal®GLUSEAL(C)HVGLUSEAL(C)HV2018-07-25
D795201GluSeal®GLUSEALPTGLUSEALPT2017-07-28
D795231PeriAcryl®P-ACRYL2(V)HVP-ACRYL2(V)HV2022-01-06
D7950000010PeriAcrylP-ACRYLU(V)2017-02-13
D7950000030PeriAcrylP-ACRYLU(C)2017-02-13
D7950000130GLUSTITCH TWISTGLTWI052017-02-13
D795G000150GLUSTITCH TWISTGLTWI05C2017-02-13
D7950000021PeriAcrylP-ACRYLU(V)2017-02-13
D7950000050PeriAcrylP-ACRYLU(V)HV2017-02-13
D7950000131GLUSTITCH TWISTGLTWI052017-02-13
D795G000151GLUSTITCH TWISTGLTWI05C2017-02-13
D795220GluSeal®90GLUSEAL0.5(ST)GLUSEAL0.5(ST)2018-08-16
D795010PeriAcryl®P-ACRYLU(V)P-ACRYLU(V)2017-02-06
D795020PeriAcryl®P-ACRYLU(C)P-ACRYLU(C)2017-02-07
D795030PeriAcryl®P-ACRYLU(V)HVP-ACRYLU(V)HV2017-02-07
D795110GluStitch® TwistGLTWI05GLTWI052017-02-07
D795120GluStitch® TwistGLTWI05CGLTWI05C2017-02-07
D795140GluSeal®90GLUSEAL(ST)CGLUSEAL(ST)C2017-04-07
D795170GluSeal®GLUSEAL(V)GLUSEAL(V)2017-04-07
D795180GluSeal®GLUSEAL(C)GLUSEAL(C)2017-04-07

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