FDA.reportPublic FDA data

Scan Mate®

Primary DI
00860009411982
Brand
Scan Mate®
Company
Armor Dental Corp.
Model
40142
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009411989PackageGS14In Commercial Distribution
00860009411982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000941198910860009411989
00860009411982008600094119828600094119820860009411982

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
035988858
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010019658MirroSoft™ TearDrop Mirror832002025-05-12
00860010019665MirroSoft™ No. 4 Mirror832102025-05-12
00860010019672MirroSoft™ No. 5 Mirror832022025-05-12
00860010019689MirroSoft™ No. 5 Double Mirror832032025-05-12
00860010019696MirroSoft™ Delta Mirror832042025-05-12
00860013984601TissuePro™ Distal Sleeve, MN Retractor83209-AC2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN Retractor832102025-05-12
00860013984625TissuePro™ Single Sleeve, MN Retractor832112025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-Use83209-SPU2025-05-12
00860009411906Tongue-Guide™ Infant Home609002023-07-13
00860009411913Scan-Mate® (Black)401002023-07-13
00860009411920Scan-Mate® (Blue) 401012023-07-13
00860009411937Comfort-Soft™ Small Mectron732062023-07-13
00860009411944Comfort-Soft™ Large Mectron732052023-07-13
00860009411951Tongue-Guide™ Standard Pro 602002023-07-13
00860009411968Comfort-Soft™ Large MouthWatch732052023-07-13
00860009411975Comfort-Soft™ Large Delta Dental732022023-07-13
00860009411999Mouth-Mate® 401022023-07-13
00860010019603Comfort-Soft™ Small 732012023-07-13
00860010019610Comfort-Soft™ Large732002023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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