FDA.reportPublic FDA data

FORTIS

Primary DI
H66824131771
Brand
FORTIS
Company
Keystone Industries
Model
24-13177
Catalog number
24-13177
Device description
FORTIS PROPHY ANGLE SOFT CUP (100/BAG )
Published
2022-11-30
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
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66824131771PrimaryHIBCC0
H66824131770Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags#

DUNS number
073503117
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H66842201141HeyGears422011442201142023-02-20
H66842201151KeySplint Soft for HeyGears422011542201152021-07-06
H66850524011Nexa3D425020542502052023-02-20
H66852233011Nexa3D425020442502042023-02-20
H6682030051iSmile070137707013772023-02-20
H66807003771Seity070037707003772016-09-15
H66807021771M&S070217707021772017-10-11
H66807027771Seity070277707027772016-10-26
H66842204400Carbon 422044042304402025-08-28
H66842204410Carbon 422044142304412025-08-28
H66842204420Carbon 422044242304422025-08-28
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H668166361BOSWORTH16636166362022-11-30
H668166961BOSWORTH16696166962022-11-30
H66811475771Keystone Industries114757711475772022-11-30
H66811475781Keystone Industries114757811475782022-11-30
H668166301BOSWORTH16630166302022-11-30
H668166321BOSWORTH16632166322022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003123Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003130Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003147Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003154Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29