FDA.reportPublic FDA data

BASIS

Primary DI
00889989080391
Brand
BASIS
Company
ORMCO CORPORATION
Model
776-2103
Device description
Dust Free Dental Alginate Impression Material
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160441000Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation2016-06-30ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989080391PrimaryGS10
10889989075578Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989080391008899890803918899890803910889989080391
1088998907557810889989075578

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight2.72Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store below 85

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags#

DUNS number
154614119
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989079494Tevdek II975-00502016-09-08
00889989079500Tevdek II975-00522016-09-08
00889989079517Tevdek II975-00542016-09-08
00889989079524Tevdek II975-00562016-09-08
00889989079531Tevdek II975-00632016-09-12
00889989079548Tevdek II975-00652016-09-12
00889989079555Tevdek II975-00672016-09-12
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08