FDA.report

PrimaDry

Primary DI
00883205033475
Brand
PrimaDry
Company
ULTRADENT PRODUCTS, INC.
Model
7663
Catalog number
7663
Device description
PrimaDry Unit Dose 50pk
Published
2021-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications

CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00883205102621PreviousGS10
00883205033475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205102621008832051026218832051026210883205102621
00883205033475008832050334758832050334750883205033475

GMDN Terms

TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature18 Degrees Celsius29 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)553-4200customerservice@ultradent.com

Regulatory Flags

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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