FDA.reportPublic FDA data

Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En

Primary DI
00840161302144
Brand
Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z451-PAT
Device description
Foam refills for Endo Guards and Endo Assist
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161311665PrimaryGS10
00840161302144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161311665008401613116658401613116650840161311665
00840161302144008401613021448401613021440840161302144

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic instrument-holding insert, single-useA device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length45Millimeter
Width23Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
48
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00840161311511Crystal HD® Mouth Mirrors50Z364SMPL-US2026-02-19
00840161311535Crystal HD® Mouth Mirrors50Z384SMPL-US2026-02-19
00840161311559Midmark - Magnetic Bur Block - 14-Hole - Neon Blue - 1 Count50Z403N-MID2026-02-19
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack50Z457SMPL-US2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack50Z459SMPL-US2026-02-19
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample Pack50Z953SMPL-US2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample Pack50Z960SMPL-US2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack50Z970SMPL-US2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack50Z976SMPL-US50Z9762026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample P50Z989SMPL-US2026-02-19
00840161301468Steri-Endo Guard - Endo Holder - Hand - White - 1 Count50Z450A50Z450A2026-02-14
00840161301475Steri-Endo Guard - Endo Holder - Hand - Blue - 1 Count50Z450B50Z450B2026-02-14
00840161301482Steri-Endo Guard - Endo Holder - Hand - Green - 1 Count50Z450D50Z450D2026-02-14
00840161301499Steri-Endo Guard - Endo Holder - Hand - Beige - 1 Count50Z450G50Z450G2026-02-14
00840161301505Steri-Endo Guard - Endo Holder - Hand - Gray - 1 Count50Z450I50Z450I2026-02-14
00840161301512Steri-Endo Guard - Endo Holder - Hand - Plum - 1 Count50Z450E50Z450E2026-02-14
00840161301529Steri-Endo Guard - Endo Holder - Hand - Teal - 1 Count50Z450J50Z450J2026-02-14
00840161301536Steri-Endo Guard - Endo Holder - Hand - Red - 1 Count50Z450M50Z450M2026-02-14
00840161301543Steri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count50Z450T50Z450T2026-02-14
00840161301550Steri-Endo Guard - Endo Holder - Hand - Copper - 1 Count50Z450U50Z450U2026-02-14

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