FDA.reportPublic FDA data

OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

Primary DI
08800000995045
Brand
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Company
Osstem Implant Co.,Ltd.
Model
K3
Device description
A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit.
Published
2022-10-28
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183347000K3Osstem Implant Co., Ltd.2019-09-04EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800000995045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000995045088000009950458800000995045

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
08800000995809N1N12026-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
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
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
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