FDA.reportPublic FDA data

Reicodent

Primary DI
04061644055012
Brand
Reicodent
Company
devemed GmbH
Model
02-753-43 C
Device description
REICO-LUX 3.0 mm Perioluxfor tooth looseningCOMFORT RS curved
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKDInstrument, Cutting, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061644055012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061644055012040616440550124061644055012

GMDN Terms#

Term, Definition table
TermDefinition
SyndesmotomeA hand-held, dental, surgical instrument designed for cutting desmodontal fibres and for detaching the alveolodental ligaments (the fibrous connective tissue surrounding the root of a tooth that separates it from and attaches it to the alveolar bone). It is typically made of high-grade stainless steel and has a long shaft with a handle at the proximal end and an angled scythe-like or knife-like blade at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679491990info@devemed.de

Regulatory Flags#

DUNS number
506826739
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
04061644037469Reicodent02-2599-00 C2020-05-04
04061644041169Reicodent02-1082020-05-04
04061644048601Reicodent02-25942020-05-04
04061644048625Reicodent02-2595-1 G2020-05-04
04061644048632Reicodent02-2595-1 S2020-05-04
04061644048649Reicodent02-2595-1 ST2020-05-04
04061644048663Reicodent02-2595-2 G2020-05-04
04061644048670Reicodent02-2595-2 S2020-05-04
04061644048731Reicodent02-2595-A2020-05-04
04061644048748Reicodent02-2595-B2020-05-04
04061644048755Reicodent02-2595-C2020-05-04
04061644048854Reicodent02-26932020-05-04
04061644048908Reicodent02-27072020-05-04
04061644048915Reicodent02-27082020-05-04
04061644048922Reicodent02-27092020-05-04
04061644048939Reicodent02-2746-12020-05-04
04061644048946Reicodent02-2746-22020-05-04
04061644048953Reicodent02-2746-32020-05-04
04061644048960Reicodent02-2746-42020-05-04
04061644048977Reicodent02-2746-52020-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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