FDA.reportPublic FDA data

Foam Insert (Accessory) (Single-Use) 48-pack

Primary DI
10840161302141
Brand
Foam Insert (Accessory) (Single-Use) 48-pack
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z451
Device description
Foam refills for Endo Guards and Endo Assist
Published
2022-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, Saliva Ejector
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840161302141PrimaryGS10
00840161302144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016130214110840161302141
00840161302144008401613021448401613021440840161302144

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system in-line filterA screening device designed to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. It is in the form of cylindrical/conical flange with numerous small openings. The device is not intended to be used as a dedicated autologous bone particle collector. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length45Millimeter
Width23Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
48
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840161311900Airway Armor® - Throat Guard - Medium - 1 Count5Z960MD2026-05-01
00840161311917Airway Armor® - Throat Guard - Small - 1 Count5Z960SM2026-05-01
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 Count5Z989LG2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - Medium5Z989MD2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - Small5Z989SM2026-04-30
00840161311948Crystal HD® Mouth Mirrors50Z384SMPL2026-04-27
00840161311955Crystal HD® - Resin Mouth Mirror - #5 Soft Grip - 1 Count Sample Pack50Z364SMPL2026-04-27
10840161304794Airway Armor®50Z960SM2022-10-07
10840161304800Airway Armor®50Z960MD2022-10-07
10840161304817Airway Armor®50Z960LG2022-10-07
00840161304797Airway Armor® - Throat Guard - Small - 25 Count50Z960SM2026-04-07
00840161304803Airway Armor® - Throat Guard - Medium - 25 Count50Z960MD2026-04-07
00840161304810Airway Armor® - Throat Guard - Large - 25 Count50Z960LG2026-04-07
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 Count50Z989LG10/162026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count50Z989MD10/162026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 Count50Z989SM10/162026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 Count50Z989LG-B10/162026-04-08
70840161307131Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 100 Count50Z989MD-B10/162026-04-08
70840161307155Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 100 Count50Z989SM-B10/162026-04-08

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