FDA.report

FRIADENT®

Primary DI
07392532229480
Brand
FRIADENT®
Company
Dentsply Implants Manufacturing GmbH
Model
45-5500
Catalog number
45-5500
Device description
Periotome Handle
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532229480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532229480073925322294807392532229480

GMDN Terms

TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
344038836
Device count
1
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

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07392532215278ANKYLOS®31021100310211002020-11-18
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07392532215865ANKYLOS®31021630310216302020-11-18
07392532215896ANKYLOS®31021647310216472020-11-18
07392532215988ANKYLOS®31021660310216602020-11-18
07392532216572ANKYLOS®31022540310225402020-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07897990302343MICROCUT MANUALTDV DENTAL LTDAEKD2025-03-04
07897990311789MICROCUT MANUALTDV DENTAL LTDAEKD2025-03-04
07897990302312MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302329MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990302336MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990332401MICROCUTTDV DENTAL LTDAEKD2025-02-28
07897990334078MICROCUTTDV DENTAL LTDAEKD2025-02-28
00885797096340RMORmo, Inc.EKD2024-08-13
00842517118713Karl SchumacherKarl Schumacher Dental, LLCEKD2024-05-06
00842517118720Karl SchumacherKarl Schumacher Dental, LLCEKD2024-05-06
07898506811793QuinelatoSchobell Industrial LtdaEKD2023-07-05
10889950110352Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKD2023-06-27
00190776362522MillenniumAVALIGN TECHNOLOGIES, INC.EKD2023-02-22
E8963438100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
E8963439100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
E8963439130SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
00887919684213Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-08
00887919198635Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198680Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198727Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919198987Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919199892Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919199922Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919202851Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919202899Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919203100Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
00887919203117Brasseler USAPeter Brasseler Holdings, LLCEKD2022-12-07
07898506811106QuinelatoSchobell Industrial LtdaEKD2022-11-28
07898506839315QuinelatoSchobell Industrial LtdaEKD2022-11-28
07898506841509QuinelatoSchobell Industrial LtdaEKD2022-11-28