FDA.reportPublic FDA data

Cabinet Top Mount Rear Delivery

Primary DI
00850043433002
Brand
Cabinet Top Mount Rear Delivery
Company
Engle Dental Systems, LLC
Model
P071438
Catalog number
P071438
Device description
Under cabinet top mount 12 o'clock rear delivery
Published
2022-12-07
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
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
00850043433002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433002008500434330028500434330020850043433002

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
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 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
00850043433170E300 Traverse Dental ChairP096540TP096540T2022-12-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
00850043433484E2 360 Delivery SystemEngle Dental Systems, LLCEIA2023-12-14
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19