FDA.reportPublic FDA data

Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack

Primary DI
00840161311702
Brand
Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z459SMPL-US
Device description
Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack
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
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161311702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161311702008401613117028401613117020840161311702

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height70Millimeter
Length121Millimeter
Width124Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
1
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
00840161302144Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En50Z451-PAT2026-02-19
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack50Z457SMPL-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840456203835JMUJMU DENTAL, INCEIE2025-12-22
00840456203842JMUJMU DENTAL, INCEIE2025-12-22
07630392912112HySolateDent4You AGEIE2025-12-18
17630392912126HySolateDent4You AGEIE2025-12-18
17630392912133HySolateDent4You AGEIE2025-12-18
D990SD10PK0Silicone Dam 10PKSmart Denture Conversions, LLCEIE2025-05-19
00359883001353True™ Dental Dam Latex Free 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001360True™ Dental Dam Latex Free 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001377True™ Dental Dam Latex Free 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001384True™ Dental Dam Latex 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001391True™ Dental Dam Latex 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001407True™ Dental Dam Latex 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001414True™ Dental Dam Latex 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001438True™ Dental Dam Latex Free 6x6 Heavy SampleDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001445True™ Dental Dam Latex 6x6 Sample PackDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006648True™ Dental Dam Latex Free 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006679EdgeDam™ Refill Heavy 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006686EdgeDam™ Refill Heavy 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006693EdgeDam™ Refill Heavy 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006709EdgeDam™ Refill Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006716EdgeDam™ Refill Medium 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006723EdgeDam™ Refill Medium 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006730EdgeDam™ Refill Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006747EdgeDam™ Refill Medium 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006754EdgeDam™ Sample Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006761EdgeDam™ Sample Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
06972902583537C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2025-01-23
05060748681720BIODAMFOUR D RUBBER COMPANY LIMITEDEIE2024-12-18