FDA.report

A-dec

Primary DI
10194665000509
Brand
A-dec
Company
A-DEC, INC.
Model
511B
Catalog number
511
Device description
A-dec 511B Chair
Published
2022-11-08
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

Related Records

Product Codes

CodeName
NRUChair, Dental, Without Operative Unit

Product Code Classifications

CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10194665000509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019466500050910194665000509

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
009617473
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665008697A-dec3453452026-02-17
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007928A-dec 54.1041.0054.1041.002025-02-11
10194665007911A-dec346134612025-01-24
10194665007164A-dec54.1003.0054.1003.002024-11-05
10194665007171A-dec54.1004.0054.1004.002024-11-05
10194665007188A-dec54.1005.0054.1005.002024-11-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
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
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151740Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151880Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
D06037062730DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273PT0DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273RW0DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706275PT0DentalezDentalez Alabama, Inc.NRU2024-11-05
10194665007324A-decA-DEC, INC.NRU2024-09-04
00304040186176EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00304040186183EssentialsHENRY SCHEIN, INC.NRU2024-08-14
00810021435855DCI EdgeDCI International, LLCNRU2024-08-02
00810021435862DCI EdgeDCI International, LLCNRU2024-08-02
00810021435961DCI EdgeDCI International, LLCNRU2024-08-02
00810021435978DCI EdgeDCI International, LLCNRU2024-08-02