KLE

Product Code: KLE


Products Classified as KLE

1285Agent, Tooth Bonding, ResinResin Tooth Bonding Agent.

Total Product Life Cycle (TPLC) Devices

1285Agent, Tooth Bonding, ResinResin Tooth Bonding Agent.

FDA Consensus Standards

Agent, Tooth Bonding, Resin [32309]21 CFR §872.3200 🔎
Agent, Tooth Bonding, Resin [35790]21 CFR §872.3200 🔎
Agent, Tooth Bonding, Resin [32841]21 CFR §872.3200 🔎

Pre-market Notifications for KLE

K221033UniPrime A, UniPrime E, UniPrime E/CS&C Polymer Silicon- Und Composite Spezialitäten GmbH
K220804Dia-X Bond UniversalDiadent Group International
K213965BeautiBond XtremeShofu Dental Corporation
K213093STEP-1 PumEtchRounding Third LLC
K210945Ultra SEPReliance Orthodontic Products, Inc
K210186PacBond OnePac-Dent, Inc.
K203760Tokuyama Universal Bond IITokuyama Dental Corporation
K201787Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.
K200682BZF-29GC America Inc.
K200462EtchPro Etching GelBelport Company, Inc., Gingi-Pak
K200153Bright Bond UniversalGENOSS Co., Ltd.
K192961ADH193M Deutschland GmbH
K192392DiaPlusDiadent Group International
K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitDiadent Group International
K191656ZipbondSDI Limited

Global Unique Device Identification Database

00366975032768Agent, Tooth Bonding, Resin
00366975013330Agent, Tooth Bonding, Resin
00366975013323Agent, Tooth Bonding, Resin
00366975002587Agent, Tooth Bonding, Resin
00366975001917Agent, Tooth Bonding, Resin
00366975001900Agent, Tooth Bonding, Resin
00366975001894Agent, Tooth Bonding, Resin
10366975001884Agent, Tooth Bonding, Resin
10353045002131Agent, Tooth Bonding, Resin
10353045002124Agent, Tooth Bonding, Resin
00353045000710Agent, Tooth Bonding, Resin
10353045000700Agent, Tooth Bonding, Resin
10353045000694Agent, Tooth Bonding, Resin
10353045000687Agent, Tooth Bonding, Resin
10353045000670Agent, Tooth Bonding, Resin

Maude Adverse Events

PRIME & BOND NTDENTSPLY DETREY GMBH2020-03-11
GLUMA DESENSITIZERKULZER GMBH - HQ2020-02-21
PRIME & BOND NT LIGHT CURED TOTAL-ETCH DENTAL ADHESIVE SYSTEMDENTSPLY CAULK2019-10-17
GLUMA DESENSITIZERKULZER GMBH2019-07-24
GLUMA DESENSITIZERKULZER, GMBH2019-07-16
GLUMA DESENSITIZERKULZER GMBH2019-07-02
AH TEMPDENTSPLY DETREY GMBH2019-06-26
GLUME DESENSITIZERKULZER GMBH2019-05-21
GLUMA DESENSITIZERKULZER, GMBH2019-05-21
GLUMAKULZER GMBH2019-04-10
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2019-03-22
PRIME&BOND ACTIVEDENTSPLY DETREY GMBH2019-03-16
PRIME&BOND ACTIVEDENTSPLY DETREY GMBH2019-03-16
PRIME&BOND ACTIVEDENTSPLY DETREY GMBH2019-03-16
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2019-02-13
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2019-01-21
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2019-01-21
PRIME&BOND ACTIVEDENTSPLY DETREY GMBH2019-01-17
GLUMA DESENSITIZERUNK2019-01-10
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2019-01-07
GLUMA DESENSITIZERKULZER GMBH2018-12-18
PRIME&BOND XPDENTSPLY DETREY GMBH2018-12-14
PRIME&BOND ACTIVEDENTSPLY DETREY GMBH2018-11-29
GLUMA DESENSITIZER POWERGELKULZER, GMBH2018-11-21
PRIME & BOND NTDENTSPLY DETREY GMBH2018-11-02
PRIME & BOND NTDENTSPLY DETREY GMBH2018-11-02
PRIME & BOND NTDENTSPLY DETREY GMBH2018-11-02
PRIME & BOND NTDENTSPLY DETREY GMBH2018-11-02
GLUMA DESENSITIZERKULZER GMBH2018-06-28
3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER3M UNITEK CORPORATION2018-06-22
3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER3M UNITEK CORPORATION2018-06-22
GLUMA DESENSITIZERKULZER, LLC2018-06-20
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-05-25
GLUMA DESENSITIZERKULZER, LLC2018-05-10
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-05-09
HS-ETCHGEL BULKPACK 60 GRAM REFILL, 46 MLSEPTODONT, INC.2018-04-23
PRIME & BOND ELECT UNIVERSAL DENTAL ADHESIVE-LIGHT CUREDENTSPLY CAULK2018-04-12
HURRISEAL DENTIN DESENSITIZERBEUTLICH PHARMACEUTICALS, LLC2018-04-12
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-04-03
GLUMA DESENSITIZERKULZER, LLC2018-03-28
PRIME & BOND ACTIVEDENTSPLY DETREY GMBH2018-03-16
PRIME & BOND ACTIVEDENTSPLY DETREY GMBH2018-03-16
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-03-01
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-02-15
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-02-15
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-01-15
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-01-15
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-01-09
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-01-02
K?R DESENSITIZEREVOLVE DENTAL TECHNOLOGIES, INC.2018-01-02
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