FDA.reportPublic FDA data

NIC TONE, MDC Dental

Primary DI
07506338300544
Brand
NIC TONE, MDC Dental
Company
MDC DENTAL
Model
NIC TONE RUBBER DAM
Device description
Nic Tone Rubber Dam Blue, Medium, 36 sheets, 6” x 6”
Published
2022-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJEFrame, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJEFrame, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506338300544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506338300544075063383005447506338300544

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

Contacts#

Phone, Email table
PhoneEmail
+523338330333tecnovigilancia@dental.com.mx

Regulatory Flags#

DUNS number
811180298
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506338322461Nic Tone, MDC Dental Rapid Liquid2025-12-09
07506338301480MDC DentalANTIVET KIT 2023-05-04
07506338322454ROGSON WAX, MDC Dental TRUE EXTRA HARD2025-05-16
07506338322430VIVIDTone 592025-05-12
07506338322447VIVIDTone 652025-05-12
07506338322416ISOTEK, MDC DentalAnterior2025-04-29
07506338322423ISOTEK, MDC DentalPosterior2025-04-29
17506338322413ISOTEK, MDC DentalAnterior2025-04-29
17506338322420ISOTEK, MDC DentalPosterior2025-04-29
07506338322393Polishine, MDC DentalPOLISHINE 100 g2025-01-29
07506338322386New Flex, MDC Dental20 lb2025-01-17
07506338322379VIVIDTone 652025-01-07
07506338322331Nic Tone, MDC Dental Rapid liquid2024-12-18
07506338322355ROGSON WAX, MDC Dental Self-Adhering Plastic Form2024-12-18
07506338322362VIVIDTone 3.52024-12-18
07506338322232NIC TONE, MDC DentalRapid Liquid2024-08-05
07506338321921ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321938ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321945ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11
07506338321952ROGSON WAX, MDC Dental ADHESIVE PREFABRICATED PLASTIC FORM2024-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2100TBS BASICSACME ENTERPRISE.EJE2026-05-16
00813677023339PDT, Inc.PDT, INC.EJE2024-06-27
00813677024985PDT, Inc.PDT, INC.EJE2024-06-27
D2483553190Plast FrameHAGER WORLDWIDE, INC.EJE2024-04-16
08800075603463OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
08800075603470OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
07506338321761Nic Tone, MDC Dental MDC DENTALEJE2023-11-17
00014081053190Plast FrameHAGER WORLDWIDE, INC.EJE2023-03-27
07630392900409HysolateDent4You AGEJE2023-02-28
07630392900416HysolateDent4You AGEJE2023-02-28
07630392900423HysolateDent4You AGEJE2023-02-28
07630392900430HysolateDent4You AGEJE2023-02-28
07630392900447HysolateDent4You AGEJE2023-02-28
07506338300575Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300667Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300674Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300681Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300698Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300704Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300568Nic Tone, MDC DentalMDC DENTALEJE2022-12-08
07506338300599Nic Tone, MDC Dental MDC DENTALEJE2022-12-08
D24835531919Plast FrameHAGER WORLDWIDE, INC.EJE2022-12-05
07506338300582Nic Tone, MDC DentalMDC DENTALEJE2022-11-04
07506338300636Nic Tone, MDC Dental MDC DENTALEJE2022-11-03
00302731714011YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731770017YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731771014YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731776019YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731777016YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731714018YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16