FDA.reportPublic FDA data

Safco DENTA-SAFE DENTAL DAM

Primary DI
00810063750220
Brand
Safco DENTA-SAFE DENTAL DAM
Company
SAFCO DENTAL SUPPLY CO.
Model
1020766
Catalog number
1020766
Device description
Heavy (0.23mm-0.28mm thickness) 6" x 6", economy box of 90
Published
2022-04-13
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

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
10810063750227PrimaryGS10
20810063750224PrimaryGS10
00810063750220Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006375022710810063750227
2081006375022420810063750224
00810063750220008100637502208100637502200810063750220

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, Hevea-latexA sheet of elastomeric material made of Hevea natural rubber latex (NRL) 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 is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020417380
Device count
90
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810063756240KIDS BUDDY Toothbrush8250071TK32025-03-19
20810063756257Power Curve Toothbrush82500830022025-03-19
20810063756264Esprit Ultra Fine Toothbrush82500872082025-03-19
20810063756271Whisper Tech Ultra-Fine Toothbrush82500926012025-03-19
20810063756288Power Curve Toothbrush8250093002-I2025-03-19
20810063756400Power Curve Extra-Soft Toothbrush8250094002XS2025-03-19
20810063756431KIDS BUDDY Toothbrush8250072TK3-I2025-03-19
20810063756585Jr Series Comfort Grip Toothbrush82500892402025-03-19
20810063756592Power Curve Extra-Soft Toothbrush8250095002XS-I2025-03-19
20810063755564Waxed Dental Floss8250016300062025-03-18
20810063756172Euro Tech Compact Sensitive Toothbrush8250007T1872025-03-18
20810063756189Waxed Dental Floss8250017300072025-03-18
20810063756196Floss Picks8250039FP2025-03-18
20810063756202Endeavor Toothbrush8250043T0202025-03-18
20810063756219Vital Fresh Toothbrush8250048T056-I2025-03-18
20810063756226Aspire Compact Toothbrush8250060T509-I2025-03-18
20810063756233PlaquePRO Interdental Proxy Brush8250066T5132025-03-18
20810063756394Polisher Compact Toothbrush8250058T4902025-03-18
20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

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
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 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