MAX-BOND

GUDID 00810152820889

Orthodontic adhesive Primer Activated kit 4 X 4 gm syringes & 7mL Primer & etchant gel syringe 4 gm

Ortho Pro Dent LLC

Orthodontic bracket adhesive
Primary Device ID00810152820889
NIH Device Record Key5b047df8-5bc3-4348-aa50-4f1d825f1c32
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAX-BOND
Version Model NumberOP961A-04
Company DUNS085719913
Company NameOrtho Pro Dent LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com
Phone941-402-6504
Emailedward@orthoprodent.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810152820889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-12
Device Publish Date2024-11-04

On-Brand Devices [MAX-BOND]

00810152820919Etchant gel refill syringe 15 gm
00810152820902Etchant gel refill syringe 4 gm
00810152820896Orthodontic adhesive Primer Activated refill syringe 4 gm
00810152820889Orthodontic adhesive Primer Activated kit 4 X 4 gm syringes & 7mL Primer & etchant gel syringe 4
00810152820872Orthodontic adhesive Primer Activated Trial kit 1X4 gm syringe
00810152820865Orthodontic adhesive Primer Activated kit 1 x 4 gm syringe & 1 bottle Primer 3 ml & 1 syringe et
00810152820858Orthodontic adhesive Light Cure Activated KIT 4X4 gm syringes & 7mL sealant & etchant gel syring
00810152820841Orthodontic adhesive Light Cure Activated Trial KIT 1x4 gm syringe
00810152820834Orthodontic adhesive Light Cure Activated refill syringe 4 gm
00810152820827Orthodontic adhesive Light Cure Activated kit 1x4gm syringe & 1 bottle resin 3 ml & 1x3 ml syrin
00810152820070Orthodontic light cure Band Cement kit contains 1 x4.5 gm Base syringe & 1 x 4.5 gm Catalyst
00810152820063Orthodontic adhesive light cure Trial Kit 1 x 5 gm Adhesive syringe & 1 x 7 ml ortho bond & Mix

Trademark Results [MAX-BOND]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAX-BOND
MAX-BOND
75393792 2227899 Dead/Cancelled
National Refractories & Minerals Corporation
1997-11-20
MAX-BOND
MAX-BOND
71690736 0651054 Dead/Expired
MEXICO REFRACTORIES COMPANY
1955-07-05

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