Product Code: ELM


Products Classified as ELM

1244Denture, Plastic, TeethPreformed Plastic Denture Tooth.

Total Product Life Cycle (TPLC) Devices

1244Denture, Plastic, TeethPreformed Plastic Denture Tooth.

FDA Consensus Standards

Denture, Plastic, Teeth [32309]21 CFR §872.3590 🔎
Denture, Plastic, Teeth [37059]21 CFR §872.3590 🔎

Pre-market Notifications for ELM

K132984SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL SIVOCLAR VIVADENT, INC.
K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWRIGHT HEALTH GROUP LTD.
K122925NEW STETIC ARTIFICIAL TEETHNEW STETIC
K122852PHYSIOSTAR NFCCANDULOR USA, INC.
K121749VERACIASHOFU DENTAL CORPORATION
K120736SR PHONARES IIIVOCLAR VIVADENT AG
K120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMERZ DENTAL GMBH
K113426VERACIA SASHOFU DENTAL CORPORATION
K101064BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN PBREDENT GMBH & CO.KG
K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHHUGE DENTAL MATERIAL CO., LTD.
K093331SR PHONARES NHCIVOCLAR VIVADENT, INC.
K092231GEBDI TRIBOS 501GEBDI DENTAL-PRODUCTS GMBH
K070591REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETHUNION DENTAL S.A./UNIDESA.ODI
K061337WIEDENT ESTETICXPDENT CORP.
K060994MONDIALHERAEUS KULZER, INC.

Global Unique Device Identification Database

10304040000974Denture, plastic, teeth
10304040000967Denture, plastic, teeth
10304040000950Denture, plastic, teeth
10304040000943Denture, plastic, teeth
10304040000936Denture, plastic, teeth
10304040000929Denture, plastic, teeth
10304040000899Denture, plastic, teeth
10304040000882Denture, plastic, teeth
10304040000875Denture, plastic, teeth
10304040000868Denture, plastic, teeth
10304040000851Denture, plastic, teeth
10304040000844Denture, plastic, teeth
10304040000837Denture, plastic, teeth
10304040000820Denture, plastic, teeth
10304040000813Denture, plastic, teeth

Maude Adverse Events

BIOFORM IPN PLASTIC TEETH (20? POSTERIORS)DENTSPLY PROSTHETICS2018-04-19
MONDIALKULZER GMBH2017-09-25
MONDIAL 6HERAEUS KULZER GMBH2013-10-30
MONDIAL 6HERAEUS KULZER GMBH2013-10-30
MONDIAL 8 (DEVICE 2)HERAEUS KULZER GMBH2013-09-26
MONDIAL 6 (DEVICE 1)HERAEUS KULZER GMBH2013-09-26
MONDIAL 8 (DEVICE 2)HERAEUS KULZER GMBH2013-09-26
MONDIAL 6 (DEVICE 1)HERAEUS KULZER GMBH2013-09-26
FLEXITIME CORRECT FLOWHERAEUS KULZER GMBH2013-09-11
FLEXITIME CORRECT FLOWHERAEUS KULZER GMBH2013-09-11
ARTIC DENTURE TEETHHERAEUS KULZER DENTAL LTD.2013-09-04
ARTIC DENTURE TEETHHERAEUS KULZER DENTAL LTD2013-09-04
MONDIAL 6HERAEUS KULZER GMBH2013-08-27
MONDIAL 6HERAEUS KULZER GMBH2013-08-27
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 61HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
MONDIAL 6HERAEUS KULZER GMBH2013-08-13
FLEXITIME CORRECT FLOW (DEVICE 2)HERAEUS KULZER GMBH2013-08-01
FLEXITIME EASY PUTTY (DEVICE 1)HERAEUS KULZER GMBH2013-08-01
FLEXITIME CORRECT FLOW (DEVICE 2)HERAEUS KULZER, GMBH2013-08-01
ARTIC DENTURE TEETHHERAEUS KULZER, GMBH2013-05-21
ARTIC DENTURE TEETHHERAEUS KULZER GMBH2013-05-21
MONDIAL 8-DEVICE 4HERAEUS KULZER GMBH2012-06-05
MONDIAL 6-DEVICE 2HERAEUS KULZER GMBH2012-06-05
MONDIAL 6-DEVICE 1HERAEUS KULZER GMBH2012-06-05
MONDIAL 8-DEVICE 3HERAEUS KULZER GMBH2012-06-05
FALSE TEETHALLCARE DENTAL2008-06-12
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