FDA.reportPublic FDA data

Profin

Primary DI
07350081491802
Brand
Profin
Company
Dentatus AB
Model
PDX
Catalog number
PDX
Device description
Profin E-Type Reciprocating Contra-Angle
Published
2025-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07350081491802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081491802073500814918027350081491802

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
355803412
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081492335SurtexRST-18RST-182025-01-30
07350081495596SurtexSST-18SST-182025-01-30
07350081495602SurtexTST-18TST-182025-01-30
07350081490515Lamineer TipsLTA-100/2LTA-100/22025-01-28
07350081490539Lamineer TipsLTA-15/2LTA-15/22025-01-28
07350081490553Lamineer TipsLTA-150/2LTA-150/22025-01-28
07350081490577Lamineer TipsLTA-30/2LTA-30/22025-01-28
07350081490591Lamineer TipsLTA-39/2LTA-39/22025-01-28
07350081490621Lamineer TipsLTA-50/2LTA-50/22025-01-28
07350081490645Lamineer TipsLTA-75/2LTA-75/22025-01-28
07350081490669Lamineer TipsLTA-C50/2LTA-C50/22025-01-28
07350081490683Lamineer TipsLTA-D100/2LTA-D100/22025-01-28
07350081490706Lamineer TipsLTA-D150/2LTA-D150/22025-01-28
07350081490720Lamineer TipsLTA-D30/2LTA-D30/22025-01-28
07350081490751Lamineer TipsLTA-D50/2LTA-D50/22025-01-28
07350081490775Lamineer TipsLTA-E50/2LTA-E50/22025-01-28
07350081490898Lamineer TipsLTA-S100/2LTA-S100/22025-01-28
07350081490911Lamineer TipsLTA-S15/2LTA-S15/22025-01-28
07350081490935Lamineer TipsLTA-S150/2LTA-S150/22025-01-28
07350081490959Lamineer TipsLTA-S30/2LTA-S30/22025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
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