FDA.reportPublic FDA data

E300 Post Delivery System

Primary DI
00850043433330
Brand
E300 Post Delivery System
Company
Engle Dental Systems, LLC
Model
P070935
Catalog number
P070935
Device description
E300 Dr's post mount delivery system
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K983285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983285000ENGLE DENTAL FAMILY OF DELIVERY SYSTEMSEngle Dental Systems1998-11-04EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043433330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433330008500434333308500434333300850043433330

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, pneumaticA pneumatically-powered device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Contacts#

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

Regulatory Flags#

DUNS number
039794292
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043433521E300 Delivery SystemP070916P0709162026-02-09
00850043433514E300 Dr./Asst Rear DeliveryP070905P0709052025-08-26
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyP071470P0714702024-11-06
00850043433491Ceiling Mount LED LightP024735P0247352024-01-29
00850043433484E2 360 Delivery SystemP070941P0709412023-12-14
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

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Primary DI, Brand, Company table
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J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
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J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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