FDA.report

E2 360 Delivery System

Primary DI
00850043433484
Brand
E2 360 Delivery System
Company
Engle Dental Systems, LLC
Model
P070941
Catalog number
P070941
Device description
Chair mounted left / right convertible delivery system with E2 control head
Published
2023-12-14
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

Contact Domains

Product Codes

CodeName
EIAUnit, Operative Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions

SubmissionSupplement
K983285000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K983285000ENGLE DENTAL FAMILY OF DELIVERY SYSTEMSEngle Dental Systems1998-11-04EIA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850043433484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433484008500434334848500434334840850043433484

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
(800)547-1906support@engledental.com

Regulatory Flags

DUNS number
039794292
Device count
1
DM exempt
false
Premarket exempt
false
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 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
00850043433002Cabinet Top Mount Rear DeliveryP071438P0714382022-12-07
00850043433163E300 Dental ChairP096540P0965402022-12-07
00850043433187360 LED LightP024730P0247302022-12-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810021439532DCI EdgeDCI International, LLCEIA2026-03-23
00810021439549DCI EdgeDCI International, LLCEIA2026-03-23
00810021439556DCI EdgeDCI International, LLCEIA2026-03-23
00810021439563DCI EdgeDCI International, LLCEIA2026-03-23
00810021439570DCI EdgeDCI International, LLCEIA2026-03-23
00810021439587DCI EdgeDCI International, LLCEIA2026-03-23
00810021439594DCI EdgeDCI International, LLCEIA2026-03-23
00810021439600DCI EdgeDCI International, LLCEIA2026-03-23
00810021439617DCI EdgeDCI International, LLCEIA2026-03-23
00810021439518DCI PartsDCI International, LLCEIA2026-03-20
00810021439525DCI PartsDCI International, LLCEIA2026-03-20
00841709122132MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122149MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122156MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122163MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709122170MidmarkMIDMARK CORPORATIONEIA2026-03-11
00841709121852MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121869MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121876MidmarkMIDMARK CORPORATIONEIA2026-02-20
00841709121883MidmarkMIDMARK CORPORATIONEIA2026-02-20
10194665008697A-decA-DEC, INC.EIA2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEIA2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEIA2026-02-13
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
07899581342707Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581342844Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343186Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343414Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343599Delivery UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31
07899581343834Water UnitAlliage S/A Indústrias Médico OdontológicaEIA2025-12-31