FDA.reportPublic FDA data

Midmark

Primary DI
00841709110030
Brand
Midmark
Company
MIDMARK CORPORATION
Model
153678CM
Catalog number
153678CM
Device description
Midmark Procenter Cabinet Mount Delivery Systems (16" Flex Arm, 13.5" Mount Arm) are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
Published
2026-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K003090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003090000MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEMMidmark Corp.2000-10-18EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709110030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709110030008417091100308417091100300841709110030

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709108860Midmark153810-001153810-0012026-09-29
00841709108877Midmark153810-002153810-0022026-09-29
00841709108884Midmark153810-003153810-0032026-09-29
00841709109805Midmark153600-020153600-0202026-09-28
00841709109812Midmark153600-021153600-0212026-09-28
00841709109843Midmark153600-304153600-3042026-09-28
00841709109850Midmark153600-305153600-3052026-09-28
00841709109874Midmark153600-504153600-5042026-09-28
00841709109881Midmark153600-505153600-5052026-09-28
00841709110054Midmark153678WL153678WL2026-09-28
00841709110061Midmark153678WS153678WS2026-09-28
00841709111846Midmark153600-001153600-0012026-09-28
00841709111853Midmark153600-002153600-0022026-09-28
00841709110337Midmark153603LR-E153603LR-E2020-05-22
00841709110344Midmark153604CE153604CE2020-05-22
00841709110375Midmark153604LRCA-E153604LRCA-E2020-05-22
00841709110382Midmark153604LR-E153604LR-E2020-05-22
00841709111839Midmark153603C153603C2020-05-22
00841709108907Midmark153592-002153592-0022020-10-30
00841709108969Midmark153758-002153758-0022020-10-30

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
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
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11