FDA.reportPublic FDA data

E300 Traverse Dental Chair

Primary DI
00850043433170
Brand
E300 Traverse Dental Chair
Company
Engle Dental Systems, LLC
Model
P096540T
Catalog number
P096540T
Device description
Cord-connected hydraulic dental chair with traverse functionality
Published
2022-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00850043433170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433170008500434331708500434331700850043433170

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.

Contacts#

Phone, Email table
PhoneEmail
(800)547-1906support@engledental.com

Regulatory Flags#

DUNS number
039794292
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
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
00850043433019Cabinet Side Mount Rear DeliveryP071450P0714502022-12-09
00850043433026Cabinet Asst Only Rear DeliveryP071460P0714602022-12-09
00850043433033AS1 Dr./Asst Rear DeliveryP070900P0709002022-12-09
00850043433040AS1 Wall Mnt Rear DeliveryP070902P0709022022-12-09
00850043433057Assistant Wall Mount ArmP070904P0709042022-12-09
00850043433064Rear DeliveryP071964P0719642022-12-09
00850043433071Silver Mobile CartP050300P0503002022-12-09
00850043433088Gold Mobile CartP050310P0503102022-12-09
00850043433095Platinum Mobile CartP050320P0503202022-12-09
00850043433101Asst Platinum CartP050330P0503302022-12-09
00850043433118Asst Silver CartP050340P0503402022-12-09
00850043433125Dr./Asst Tabletop CartP050135P0501352022-12-09
00850043433132Asst Tabletop CartP050145P0501452022-12-09
00850043433149Dr. Flip Top CartP050140P0501402022-12-09
00850043433156Hygiene Flip Top CartP050150P0501502022-12-09
00850043433194Utility Center Mount LED LightP024720P0247202022-12-09
00850043433200Post Mount LED LightP024710P0247102022-12-09
00850043433217Post Mount LED Light for Non-EngleP024715P0247152022-12-09
00850043433224Utility Center Mount LED Light for Non-EngleP024725P0247252022-12-09
00850043433231E300 360 Delivery SystemP070931P0709312022-12-09

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