FDA.reportPublic FDA data

Ceri-Sander™

Primary DI
D8130313375100
Brand
Ceri-Sander™
Company
DEN-MAT HOLDINGS, LLC
Model
031337510
Catalog number
031337510
Device description
CERISANDER STRIPS FINE 6pc LG
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8130313375101PrimaryHIBCC0
D8130313375100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004336628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06
00359883007218EVANESCE0322200322202025-10-08
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL3453023453022025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL3455033455032025-03-12
D8130301255000Ceri-Prime0301255000301255002016-09-24
D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002053Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

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Primary DI, Brand, Company table
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