FDA.reportPublic FDA data

OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

Primary DI
08800000996264
Brand
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Company
Osstem Implant Co.,Ltd.
Model
K5
Device description
The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.
Published
2025-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental
KLCChair, Dental, With Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1
KLCChair, Dental, With Operative UnitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251491000K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business2025-07-17EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800000996264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000996264088000009962648800000996264

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.

Regulatory Flags#

DUNS number
696467699
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800040673866HySil Impression Materials (Heavy, Mono, and Bite)ESS380H2020-11-17
08800040673873HySil Impression Materials (Heavy, Mono, and Bite)ESS380M2020-11-17
08800040673880HySil Impression MaterialsESS400P2020-11-17
08800040673897HySil Impression Materials (Heavy, Mono, and Bite)ESS50B2020-11-17
08800040673903HySil Impression MaterialsESS50EL2020-11-17
08800040673910HySil Impression MaterialsESS50HB2020-11-17
08800040673927HySil Super Fast Impression MaterialsESS50HF2020-11-17
08800040673934HySil Super Fast Impression MaterialsESS50HFB2020-11-17
08800040673941HySil Super Fast Impression MaterialsESS50HFD2020-11-17
08800040673958HySil Impression MaterialsESS50H2020-11-17
08800040673965HySil Impression MaterialsESS50LB2020-11-17
08800040673972HySil Super Fast Impression MaterialsESS50LF2020-11-17
08800040673989HySil Super Fast Impression MaterialsESS50LFB2020-11-17
08800040673996HySil Super Fast Impression MaterialsESS50LFD2020-11-17
08800040674009HySil Impression MaterialsESS50L2020-11-17
08800040674016HySil Impression MaterialsESS50MB2020-11-17
08800040674023HySil Super Fast Impression MaterialsESS50MF2020-11-17
08800040674030HySil Super Fast Impression MaterialsESS50MFB2020-11-17
08800040674047HySil Super Fast Impression MaterialsESS50MFD2020-11-17
08800040674054HySil Impression MaterialsESS50M2020-11-17

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Primary DI, Brand, Company table
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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
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08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
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J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
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J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
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