FDA.reportPublic FDA data

Water Wise

Primary DI
00840161304179
Brand
Water Wise
Company
ZIRC DENTAL PRODUCTS, INC.
Model
23Z105
Device description
"""Water Wise Replacement Bottle1 x Bottle1 x Lid1 x Neon Blue Water Level Indicator (Bubbles)1 x Yellow Water Level Indicator (Bubbles)"""
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBRUnit, Suction Operatory
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBRUnit, Suction OperatoryDental1
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161304179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161304179008401613041798401613041790840161304179

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation bottleAn empty plastic container, typically with a relatively narrow neck, intended to be filled with a fluid (e.g., distilled water) and connected to an irrigation unit for the irrigation of the oral cavity during a dental procedure; it is not intended for the storage of the fluid. It may be provided with a lid, tubing, connector(s), or non-powered valve(s); it does not include patient contact devices. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height264Millimeter
Length83Millimeter
Width83Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840161311894Airway Armor® - Throat Guard - Large - 1 Count5Z960LG2026-05-01
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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