FDA.reportPublic FDA data

AS-1 Post Delivery System

Primary DI
00850043433361
Brand
AS-1 Post Delivery System
Company
Engle Dental Systems, LLC
Model
P070875
Catalog number
P070875
Device description
AS-1 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
00850043433361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433361008500434333618500434333610850043433361

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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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
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