FDA.reportPublic FDA data

TissuePro™ Distal Sleeve, MN Retractor

Primary DI
00860013984601
Brand
TissuePro™ Distal Sleeve, MN Retractor
Company
Armor Dental Corp.
Model
83209-AC
Published
2025-05-12
Public version status
New
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
00860013984601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013984601008600139846018600139846010860013984601

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

Regulatory Flags#

DUNS number
035988858
Device count
1
Premarket exempt
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
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
00860010019627Tongue-Guide™ Infant Pro 608002023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07