FDA.report

Proma

Primary DI
D142DCU01
Brand
Proma
Company
Proma, Inc.
Model
Control Unit
Device description
Dental Control Unit
Published
2024-01-18
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

Product Codes

CodeName
EIAUnit, Operative Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions

SubmissionSupplement
K980106000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K980106000THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIESProma, Inc.1998-08-03EIA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D142DCU01PrimaryHIBCC0

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

Regulatory Flags

DUNS number
067732495
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
D142DLT010PromaLight2024-01-18

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