FDA.reportPublic FDA data

PeriAcryl®

Primary DI
D795231
Brand
PeriAcryl®
Company
Glustich Inc
Model
P-ACRYL2(V)HV
Catalog number
P-ACRYL2(V)HV
Device description
PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
D795231PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
1-877-940-2262info@glustitch.com

Regulatory Flags#

DUNS number
201637158
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D795210GluSeal®GLUSEAL(C)HVGLUSEAL(C)HV2018-07-25
D795201GluSeal®GLUSEALPTGLUSEALPT2017-07-28
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
D7950000041PeriAcrylP-ACRYLU(C)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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