FDA.reportPublic FDA data

n/a

Primary DI
00858308006022
Brand
n/a
Company
Ergonomic Products, Inc.
Model
D1B1
Catalog number
D1B1
Device description
Horizon Workstation
Published
2022-09-07
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

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
K132315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132315000ERGONOMIC PRODUCTS WORKSTATIONErgonomic Products, Inc.2014-04-18EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858308006022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858308006022008583080060228583080060220858308006022

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-488-4793equip@ergonmic-products.com

Regulatory Flags#

DUNS number
051194887
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
00858308006534Harmony Open Bay WorkstationD1H1D1H12025-04-15
00858308006527N/AD1F2D1F22023-06-06
00858308006510N/AD1F1D1F12023-01-03
00858308006435n/aD1C1D1C12022-09-07
00858308006336n/aD1D4D1D42022-08-19
00858308006343n/aD1D1D1D12022-08-19
00858308006350n/aD1D2D1D22022-08-19
00858308006367n/aD1E2D1E22022-08-19
00858308006374n/aD1E4D1E42022-09-07
00858308006381n/aD1E1D1E12022-08-19
00858308006398n/aD1B4D1B42022-08-19
00858308006404n/aD1B2D1B22022-09-07
00858308006411n/aD1E3D1E32022-08-19
00858308006428n/aL2A1L2A12022-09-07
00858308006442n/aS1A1S1A42022-09-07
00858308006459n/aS1A2S1A22022-09-07
00858308006466n/aS1A3S1A32022-09-07
00858308006473n/aS1A4S1A42022-09-07
00858308006480n/aD3A1D3A12022-09-07
00858308006497n/aD2A1D2A12022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
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
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
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10817417021606AsepticoASEPTICO, INC.EIA2022-12-08
10817417021613AsepticoASEPTICO, INC.EIA2022-12-08
10817417021835AsepticoASEPTICO, INC.EIA2022-12-08
10817417021842AsepticoASEPTICO, INC.EIA2022-12-08