FDA.reportPublic FDA data

PROIII 047

Primary DI
04952195359264
Brand
PROIII 047
Company
TAKARA BELMONT CORP.
Model
AC-47R-FD36US
Catalog number
AC-47R-FD36US
Device description
PROIII 047
Published
2022-06-22
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
NRUChair, Dental, Without Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04952195359264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04952195359264049521953592644952195359264

GMDN Terms#

Term, Definition table
TermDefinition
Dental chair, electricA mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-20 Degrees Fahrenheit70 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
732 4695000gstern@belmontequip.com

Regulatory Flags#

DUNS number
690540349
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04952195235728PHOT-X II, MODEL 303AR-33WKCNJ1AR-33WKCNJ12026-05-11
04952195347414PHOT-X II, MODEL 303AR-33WKCNJ3AR-33WKCNJ32026-05-11
04952195347421PHOT-X II, MODEL 303AR-33WKCNJ5AR-33WKCNJ52026-05-11
04952195347438PHOT-X II, MODEL 303AR-33WKCNJ8AR-33WKCNJ82026-05-11
04952195483259Evogue Dental UnitAU-HV3610AU-HV36102026-05-11
04952195462339Evogue Dental UnitAU-HV3420C-USAU-HV3420C-US2025-03-26
04952195372331Bel-Nova LEDBel-Nova LEDAL-D107G-NA-H2020-11-20
04952195436170DG-770-RSTAW-G091X2023-11-08
04952195354627DG-770-FAW-G090X2021-06-11
04952195406692Bel-Halo Dental LightAL-D241G-NAAL-D241G-NA2023-06-16
04952195406708Bel-Halo Dental LightAL-D241W-NAAL-D241W-NA2023-06-16
04952195406715Bel-Halo Dental LightAL-D242G-NAAL-D242G-NA2023-06-16
04952195406722Bel-Halo Dental LightAL-D245G-NA-HAL-D245G-NA-H2023-06-16
04952195406739Bel-Halo Dental LightAL-D246G-EVAL-D246G-EV2023-06-16
04952195406746Bel-Halo Dental LightAL-D246G-QUAL-D246G-QU2023-06-16
04952195406753Bel-Halo Dental LightAL-D247G-NAAL-D247G-NA2023-06-16
04952195406760Bel-Halo Dental LightAL-D248G-NA-HAL-D248G-NA-H2023-06-16
04952195406777Bel-Halo Dental LightAL-D249W-XAL-D249W-X2023-06-16
04952195406784Bel-Halo Dental LightAL-D249W-XNAL-D249W-XN2023-06-16
04952195408504Evogue Dental UnitAU-HV3401WAU-HV3401W2023-06-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
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06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
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