PULSETEMP PTA2

GUDID D650PTA20

SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge
Primary Device IDD650PTA20
NIH Device Record Key47b65c81-15a0-4de1-8a47-6812177fb51b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePULSETEMP
Version Model NumberSHADE A2 50 ML CARTRIDGE 10:1
Catalog NumberPTA2
Company DUNS005185798
Company NameLANG DENTAL MANUFACTURING CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM
Phone847-215-6622
EmailORDERS@LANGDENTAL.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD650PTA20 [Primary]

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-23
Device Publish Date2026-01-15

On-Brand Devices [PULSETEMP]

D650PTA30SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
D650PTA20SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
D650PTA10SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL

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