FDA.report

Ultra-Etch

Primary DI
00883205103451
Brand
Ultra-Etch
Company
ULTRADENT PRODUCTS, INC.
Model
163
Catalog number
163
Device description
Ultra-Etch 35% Kit
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00883205103451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205103451008832051034518832051034510883205103451

GMDN Terms

TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius29 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)572-4200customerservice@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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