TEMPO POWDER 1070P1

GUDID D6501070P10

CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER

LANG DENTAL MANUFACTURING CO., INC.

Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional Denture reliner, soft, professional
Primary Device IDD6501070P10
NIH Device Record Key6c48d0a7-f3bf-44ef-be1f-9c3ef07c587c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMPO POWDER
Version Model Number11.3 KG P1
Catalog Number1070P1
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6501070P10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-05
Device Publish Date2023-06-27

Devices Manufactured by LANG DENTAL MANUFACTURING CO., INC.

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D6500934F10 - FLEXACRYL HARD2023-07-05 DENTURE RELINE ACRYLIC POWDER AND LIQUID
D6500950CLR0 - FLEXACRYL2023-07-05 DENTURE RELINE ACRYLIC RESIN POWDER
D6501070P10 - TEMPO POWDER2023-07-05CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER
D6501070P10 - TEMPO POWDER2023-07-05 CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER
D6501330LS0 - ORTHO-JET POWDER2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER
D6501356PT0 - ORTHO-JET2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID
D6501480LI0 - JET TOOTH SHADE POWDER2023-07-05 FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN
D6504720F20 - JET SET-4 DENTURE REPAIR2022-10-28 VERY FAST CURING DENTURE REPAIR ACRYLIC RESIN POWDER
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