FDA.report

Amalgam Catches

Primary DI
00723896009291
Brand
Amalgam Catches
Company
PRACTICON, INC.
Model
70-14420
Catalog number
70-14420
Device description
Original Amalgam Catches "convert" a mouth mirror into a collection cup that helps prevent amalgam debris from falling down the throat. Plastic clip-on design reduces mirror fogging by shielding the glass from the patient's breath. Adds revenue by increasing valuable scrap recovery and recycling too
Published
2018-07-11
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
true

Related Records

Product Codes

CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896009291PrimaryGS10
00723896001004Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896009291007238960092917238960092910723896009291
00723896001004007238960010047238960010040723896001004

GMDN Terms

TermDefinition
Dental amalgam trapA device designed to prevent waste amalgam from entering a mains drainage system.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
100
DM exempt
false
Premarket exempt
true
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

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