FDA.reportPublic FDA data

Plasdent

Primary DI
D832LHD0010
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
LHD-001
Catalog number
LHD-001
Device description
Light Handle Set for DCI/Marus 1200
Published
2022-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832LHD0011PrimaryHIBCC0
D832LHD0010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Reflective dental room lightA mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
D832CFT11PlasdentCFT-1CFT-12026-10-13
D832FT11PlasdentFT-1FT-12026-10-13
D832SAP21PlasdentSAP-2SAP-22026-10-13
D832SAP31PlasdentSAP-3SAP-32026-10-13
D832SAPR21PlasdentSAP-R2SAP-R22026-10-13
D832SAPR31PlasdentSAP-R3SAP-R32026-10-13
D832CT10L1PlasdentCT10-LCT10-L2026-10-12
D832CT10M1PlasdentCT10-MCT10-M2026-10-12
D832CT10S1PlasdentCT10-SCT10-S2026-10-12
D832CT10XL1PlasdentCT10-XLCT10-XL2026-10-12
D832CT2L1PlasdentCT2-LCT2-L2026-10-12
D832CT2M1PlasdentCT2-MCT2-M2026-10-12
D832CT2S1PlasdentCT2-SCT2-S2026-10-12
D832CT2XL1PlasdentCT2-XLCT2-XL2026-10-12
D832CT2XXL1PlasdentCT2-XXLCT2-XXL2026-10-12
D832CT6L1PlasdentCT6-LCT6-L2026-10-12
D832CT6M1PlasdentCT6-MCT6-M2026-10-12
D832CT6S1PlasdentCT6-SCT6-S2026-10-12
D832CT6XL1PlasdentCT6-XLCT6-XL2026-10-12
D832JK10L1PlasdentJK10-LJK10-L2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08