FDA.reportPublic FDA data

CLEARSPLINT

Primary DI
D810PCSREK11
Brand
CLEARSPLINT
Company
ASTRON DENTAL CORPORATION
Model
PCSREK1
Catalog number
PCSREK1
Device description
DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111828000CLEARSPLINT ESAstron Dental Corporation2011-10-26MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D810PCSREK11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-726-8787ASTRONCORP@AOL.COM

Regulatory Flags#

DUNS number
056624901
Device count
1
Kit
true
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
D810PCSD1695Z111CLEARSPLINTPCSD1695Z1PCSD1695Z12023-01-27
D810PCSD2095ZBESB111CLEARSPLINTPCSD2095ZBESB1PCSD2095ZBESB12023-01-27
D810PCSD2095ZBESM111CLEARSPLINTPCSD2095ZBESM1PCSD2095ZBESM12023-01-27
D810PCSD2098BESB111CLEARSPLINTPCSD2098BESB1PCSD2098BESB12023-01-27
D810PCSD2098BESM111CLEARSPLINTPCSD2098BESM1PCSD2098BESM12023-01-27
D810PCSD2595ZBES111CLEARSPLINTPCSD2595ZBES1PCSD2595ZBES12023-01-27
D810PCSD2595ZBESB111CLEARSPLINTPCSD2595ZBESB1PCSD2595ZBESB12023-01-27
D810PCSD2595ZBESM111CLEARSPLINTPCSD2595ZBESM1PCSD2595ZBESM12023-01-27
D810PCSD2598BES111CLEARSPLINTPCSD2598BES1PCSD2598BES12023-01-27
D810PCSD2598BESB111CLEARSPLINTPCSD2598BESB1PCSD2598BESB12023-01-27
D810PCSD2598BESM111CLEARSPLINTPCSD2598BESM1PCSD2598BESM12023-01-27
D810PCSD1698111The Original Clearsplint DiscPCSD16PCSD162021-07-16
D810PCSD2095Z111The Original Clearsplint DiscPCSD95PCSD952021-07-16
D810PCSD2098NS111The Original Clearsplint DiscPCSD98NPCSD98N2021-07-16
D810PCSD985111The Original Clearsplint DiscPCSD98PCSD982021-07-16
D8101180EC11ASTRON 11801180EC11180EC12016-09-07
D8101180LFT11ASTRON 11801180LFT11180LFT12016-09-07
D8101180MFT11ASTRON 11801180MFT11180MFT12016-09-07
D810LCH818ASTRON LCLCH81LCH812016-09-07
D810LCHE11ASTRON LCLCHE1LCHE12016-09-07

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