FDA.reportPublic FDA data

CLEARSPLINT

Primary DI
D810PCSD1695Z111
Brand
CLEARSPLINT
Company
ASTRON DENTAL CORPORATION
Model
PCSD1695Z1
Catalog number
PCSD1695Z1
Device description
Clearsplint Disc 95mm x 16mm Clover Edge Clear 1 Unit
Published
2023-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
D810PCSD1695Z111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, single-useA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
847-726-8787doug@astrondental.com

Regulatory Flags#

DUNS number
056624901
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
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
D810LCS818ASTRON LCLCS81LCS812016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
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04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
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