FDA.reportPublic FDA data

Patterson®

Primary DI
D6620710313762
Brand
Patterson®
Company
PATTERSON DENTAL SUPPLY, INC.
Model
71031376
Catalog number
71031376
Device description
MATERIAL, IMPRESSION
Published
2018-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012767000S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALS & C Polymer GmbH2001-11-01ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6620710313762PrimaryHIBCC0
D6620710313760Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
171843584
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D66207043102302Patterson®043-1023704310232024-11-11
D6620704340920Patterson®043-4092704340922024-11-11
D6620708296480PATTERSON0708296482018-09-18
D6620708394560PATTERSON0708394562018-09-18
D6620708996740PATTERSON 089-96742015-09-25
D6620708325012PATTERSON0708325012016-09-23
D6620708325192PATTERSON0708325192016-09-23
D6620704115790Patterson®70411579704115792016-09-23
D6620708903840Patterson®70890384708903842016-09-23
D66207111063405Patterson®71110634711106342024-05-08
D6620711869150Patterson®71186915711869152024-05-08
D6620711869310Patterson®71186931711869312024-05-08
D6620714708480Patterson®25-PAT714708482025-02-06
D6620714708550Patterson®15-PAT714708552025-02-06
D6620714708630Patterson®65-PAT714708632025-02-06
D6620714708710Patterson®204-PAT714708712025-02-06
D6620714708890Patterson®57-PAT714708892025-02-06
D6620714969590Patterson®22-PAT714969592025-02-06
D6620708506692Patterson®70850669708506692016-09-23
D6620708506932Patterson®70850693708506932016-09-23

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