FDA.reportPublic FDA data

Allgilloid Plus™ Chromatic Mint Alginate

Primary DI
00842452100712
Brand
Allgilloid Plus™ Chromatic Mint Alginate
Company
ORTHO SPECIALTIES
Model
600-643M
Catalog number
600-643M
Device description
Chromatic (Color Changing) Impression Material For Dental Molds / Mint Flavor
Published
2016-09-24
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
K974894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974894000KROMATICA COLOR CHANGING ALGINATEMatech, Inc.1998-02-12ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842452100712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842452100712008424521007128424521007120842452100712

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

Contacts#

Phone, Email table
PhoneEmail
800-637-1237contactus@orthospecialties.com

Regulatory Flags#

DUNS number
011050583
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842452100491Adhere™ Light Cure Adhesive 5g Syringe600-369600-3692016-09-24
00842452100507Adhere™ Light Cure Adhesive Kit600-370600-3702016-09-24
00842452100514Adhere™ Light Cure Adhesive Tips600-371600-3712016-09-24
00842452100521Adhere™ Light Cure Adhesive Primer600-372600-3722016-09-24
00842452100538Adhere™ Enamel Etch Conditioner600-373600-3732016-09-24
00842452100545Adhere™ Self Cure Adhesive Kit600-385600-3852016-09-24
00842452100552Adhere™ Self Cure Adhesive Tips600-386600-3862016-09-24
00842452100569Adhere™ Self Cure Activator600-387600-3872016-09-24
00842452100576Adhere™ Self Cure Adhesive 5g Syringe600-388600-3882016-09-24
00842452100583LockTight™ Auto Mix Band Cement Blue600-400600-4002016-09-24
00842452100590Locktight™ Auto Mix Band Cement Natural600-401600-4012016-09-24
00842452100606Multi-Adjustable Facemask600-524600-5242016-09-24
00842452100613American Flag Class III Adjustable Facemask600-525600-5252016-09-24
00842452100620Hawaiian Print Class III Adjustable Facemask600-526600-5262016-09-24
00842452100637Flames Class III Adjustable Facemask600-527600-5272016-09-24
00842452100644Leopard Print Class III Adjustable Facemask600-528600-5282016-09-24
00842452100651Safety Release Modules Light600-557600-5572016-09-24
00842452100668Saftey Release Modules Medium600-558600-5582016-09-24
00842452100675Safety Release Modules Heavy600-559600-5592016-09-24
00842452100705Allgilloid Plus™ Chromatic Cherry Alginate600-643C600-643C2016-09-24

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