FDA.reportPublic FDA data

Calm-it™ Desensitizer

Primary DI
D00261A0041
Brand
Calm-it™ Desensitizer
Company
DENTSPLY INTERNATIONAL INC.
Model
61A004
Catalog number
61A004
Device description
Calm-It™ Desensitizer Unit Dose Refill
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVARNISH, CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00261A00432PackageHIBCC3Not in Commercial Distribution
D00261A0041PrimaryHIBCC0
D00261A0040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight.

Contacts#

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

Regulatory Flags#

DUNS number
083235549
Device count
40
DM exempt
true
Lot or batch
true
Expiration date on label
true

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