FDA.reportPublic FDA data

Reicodent

Primary DI
04061644037384
Brand
Reicodent
Company
devemed GmbH
Model
02-2500-15 C
Device description
Periotome2.0 mm, straightCOMFORT SL single ended
Published
2020-04-22
Public version status
Update
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
04061644037384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061644037384040616440373844061644037384

GMDN Terms#

Term, Definition table
TermDefinition
Periotome, reusableA hand-held dental instrument used during tooth extraction to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process). This procedure reduces the need for luxation of the tooth and minimizes mechanical trauma to the bone tissue. The device is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. 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
00850083275662Intrace USAPILOTIS TECH LLCEKD2026-07-03
00348783008333Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008340Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008357Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783012248Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008265Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
07392532229480FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229497FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229503FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229510FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
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