FDA.reportPublic FDA data

N2

Primary DI
08809822769964
Brand
N2
Company
Megagen Implant Co. Ltd
Model
N2 (Cart A Type)
Catalog number
MC92-0001A
Published
2023-11-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211556000N2Megagen Implant Co., Ltd.2023-04-05EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809822769964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809822769964088098227699648809822769964

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
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
08806388266173ZrGEN AbutmentARZXM503825ARZXM503825.MTN2024-01-31
08806388244812ZrGEN AbutmentARZXM5015ARZXM5015.MTN2023-06-22
08806388244829ZrGEN AbutmentARZXM5525ARZXM5525.MTN2023-06-22
08806388244836ZrGEN AbutmentARZXM5016ARZXM5016.MTN2023-06-22
08806388244843ZrGEN AbutmentARZXM5526ARZXM5526.MTN2023-06-22
08806388244850ZrGEN AbutmentARZXM5015NARZXM5015N.MTN2023-06-22
08806388244867ZrGEN AbutmentARZXM5525NARZXM5525N.MTN2023-06-22
08806388244874ZrGEN AbutmentARZXM5016NARZXM5016N.MTN2023-06-22
08806388244898ZrGEN AbutmentARZXL5515ARZXL5515.MTN2023-06-22
08806388244904ZrGEN AbutmentARZXL6025ARZXL6025.MTN2023-06-22
08806388244911ZrGEN AbutmentARZXL5516ARZXL5516.MTN2023-06-22
08806388244928ZrGEN AbutmentARZXL6026ARZXL6026.MTN2023-06-22
08806388244935ZrGEN AbutmentARZXL5515NARZXL5515N.MTN2023-06-22
08806388244942ZrGEN AbutmentARZXL6025NARZXL6025N.MTN2023-06-22
08806388244959ZrGEN AbutmentARZXL5516NARZXL5516N.MTN2023-06-22
08806388244966ZrGEN AbutmentARZXL6026NARZXL6026N.MTN2023-06-22
08806388256624ZrGEN AbutmentAROZGN4015AROZGN4015T2023-06-22
08806388256631ZrGEN AbutmentAROZGN4025AROZGN4025T2023-06-22
08806388256648ZrGEN AbutmentAROZGR4515AROZGR4515T2023-06-22
08806388256655ZrGEN AbutmentAROZGR4525AROZGR4525T2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
10817417020098AsepticoASEPTICO, INC.EIA2022-12-08
10817417020135AsepticoASEPTICO, INC.EIA2022-12-08
10817417021309AsepticoASEPTICO, INC.EIA2022-12-08
10817417021507AsepticoASEPTICO, INC.EIA2022-12-08
10817417021514AsepticoASEPTICO, INC.EIA2022-12-08
10817417021521AsepticoASEPTICO, INC.EIA2022-12-08
10817417021538AsepticoASEPTICO, INC.EIA2022-12-08
10817417021545AsepticoASEPTICO, INC.EIA2022-12-08
10817417021552AsepticoASEPTICO, INC.EIA2022-12-08
10817417021569AsepticoASEPTICO, INC.EIA2022-12-08
10817417021576AsepticoASEPTICO, INC.EIA2022-12-08
10817417021583AsepticoASEPTICO, INC.EIA2022-12-08
10817417021590AsepticoASEPTICO, INC.EIA2022-12-08
10817417021606AsepticoASEPTICO, INC.EIA2022-12-08
10817417021613AsepticoASEPTICO, INC.EIA2022-12-08
10817417021835AsepticoASEPTICO, INC.EIA2022-12-08
10817417021842AsepticoASEPTICO, INC.EIA2022-12-08