Home GUDID D6500934FIB0 FLEXACRYL HARD
Primary DI D6500934FIB0
Brand FLEXACRYL HARD
Company LANG DENTAL MANUFACTURING CO., INC.
Model POUND PACKAGE FIBRED PINK
Catalog number 0934FIB
Device description DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
Published 2017-12-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name EBI Resin, Denture, Relining, Repairing, Rebasing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBI Resin, Denture, Relining, Repairing, Rebasing Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D6500934FIB0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Denture reliner, soft, professional A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
Regulatory Flags# DUNS number 005185798 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D650PTA10 PULSETEMP SHADE A1 50 ML CARTRIDGE 10:1 PTA1 2026-01-15 D650PTA20 PULSETEMP SHADE A2 50 ML CARTRIDGE 10:1 PTA2 2026-01-15 D650PTA30 PULSETEMP SHADE A3 50 ML CARTRIDGE 10:1 PTA3 2026-01-15 D6501508YEL0 CONTEMPORARY ORTHO-JET LIQUID 19 L YELLOW 1508YEL 2017-12-01 D6500270C0 ORTHO-JET CRYSTAL POWDER 11.3 KG 0270C 2023-06-27 D6500934F10 FLEXACRYL HARD POUND PACKAGE F1 0934F1 2023-06-27 D6500950CLR0 FLEXACRYL 2.7 KG CLEAR 0950CLR 2023-06-27 D6501070P10 TEMPO POWDER 11.3 KG P1 1070P1 2023-06-27 D6501330LS0 ORTHO-JET POWDER 1 LB LOW SLUMP 1330LS 2023-06-27 D6501356PT0 ORTHO-JET FIVE POUND PACKAGE PINK TINT 1356PT 2023-06-27 D6501480LI0 JET TOOTH SHADE POWDER 45.4 KG SHADE LIGHT INCISAL 1480LI 2023-06-27 D65038H0DRK0 JET SET-4 TOOTH SHADE POWDER 250 GRAMS SHADE DARK 38H0DRK 2016-09-01 D6504720F20 JET SET-4 DENTURE REPAIR 100 GRAM F2 4720F2 2022-10-20 D6504720P10 JET SET-4 DENTURE REPAIR 100 GRAM P1 4720P1 2022-10-20 D6504723F20 JET SET-4 DENTURE REPAIR PROFESSIONAL PACKAGE F2 4723F2 2022-10-20 D6504723P10 JET SET-4 DENTURE REPAIR PROFESSIONAL PACKAGE P1 4723P1 2022-10-20 D6504730F20 JET SET-4 DENTURE REPAIR 454 GRAM F2 4730F2 2022-10-20 D6504730P10 JET SET-4 DENTURE REPAIR 454 GRAMS P1 4730P1 2022-10-20 D6504734F20 JET SET-4 DENTURE REPAIR POUND PACKAGE F2 4734F2 2022-10-20 D6504734P10 JET SET-4 DENTURE REPAIR POUND PACKAGE P1 4734P1 2022-10-20
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