FDA.report

Safco DENTA-SAFE NON-LATEX DENTAL DAM

Primary DI
00810063750152
Brand
Safco DENTA-SAFE NON-LATEX DENTAL DAM
Company
SAFCO DENTAL SUPPLY CO.
Model
1020779
Catalog number
1020779
Device description
Heavy (0.23mm-0.28mm thickness) 5" x 5", economy box of 100
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

Related Records

Product Codes

CodeName
EIEDAM, RUBBER

Product Code Classifications

CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810063750159PrimaryGS10
20810063750156PrimaryGS10
00810063750152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006375015910810063750159
2081006375015620810063750156
00810063750152008100637501528100637501520810063750152

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
100
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

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20810063756530Soft Flex Toothbrush8250054T183-I2025-03-18
20810063756547Glisten Junior Toothbrush8250064T511-I2025-03-18

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Primary DIBrandCompanyProduct codePublished
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00359883001391True™ Dental Dam Latex 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
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00359883001438True™ Dental Dam Latex Free 6x6 Heavy SampleDEN-MAT HOLDINGS, LLCEIE2025-03-12
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00359883006723EdgeDam™ Refill Medium 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
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