FDA.reportPublic FDA data

Barricaid® Visible Light Cure Periodontal Surgical Dressing

Primary DI
D0026390521
Brand
Barricaid® Visible Light Cure Periodontal Surgical Dressing
Company
DENTSPLY INTERNATIONAL INC.
Model
639052
Catalog number
639052
Device description
Barricaid® Visible Light Cure Periodontal Surgical Dressing - 9 cartons or 4 Syringe Units
Published
2016-09-21
Public version status
Update
Distribution status
Not 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
K864720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864720000LIGHT-CURED PERIODONTAL DRESSINGDentsply Intl.1987-04-07EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026390521PrimaryHIBCC0
D0026390520Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
36
DM exempt
true
Lot or batch
true
Expiration date on label
true

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