FDA.reportPublic FDA data

PRISMATIK DENTALCRAFT, INC.

Matched from indexed company URL: PRISMATIK DENTALCRAFT INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116493143011649314PRISMATIK DENTALCRAFT, INC.1Y2026-01-012144 Michelson Drive Irvine CA US 92612
30272481323027248132Prismatik Dentalcraft, Inc.1Y2026-01-0117466 DAIMLER STREET Irvine CA US 92614

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
D745701153PRA00910Hahn - Hahn Tapered Implant Titanium Abutment 6 mmH - Ø3.5/4.3 Implant+1(949)251-1269Marilyn.Pourazar@glidewelldental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2067861355132668K972424SILENTNITELRK1997-09-18
2067861291536863K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCELRK1997-09-29
2067861892914017K953235SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3DZE1995-09-13
2067861393418331K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELW1995-03-31
2067861579238765K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsNHA2025-11-18
2067861836338872K250302Flexible Partial ResinEBI2025-06-25
2067861820505952K250223BruxZir® Esthetic NOWEIH2025-02-25
2067861024296331K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)KCT2025-03-21
2067861521870174K241493Glidewell™ 3DP Denture Base ResinEBI2024-09-12
2067861747408155K240882BruxZir® EstheticEIH2024-05-01
2067861780150675K240574BruxZir® RadiantEIH2024-03-20
2067861508339755K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsNHA2024-07-12
2067861553893804K234014Obsidian® NOWEIH2024-02-27
2067861595955925K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)LRK2023-11-14
2067861260124711K231940BruxZir® NOW SRCNHA2024-05-15
2067861353524154K231529CloudPoint FastDesign ChairsidePNP2024-03-14
2067861362468184K231347BruxZir™ TintEFX Coloring LiquidEIH2023-06-09
2067861422556790K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant SystemsNHA2023-11-14
2067861202610329K230262BruxZir™ Incisal Coloring LiquidEIH2023-05-16
2067861132281293K223798Glidewell TuffSplint™ Appliance ResinMQC2023-02-17
2067861744771056K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant SystemsNHA2023-09-26
2067861099605161K221033UniPrime A, UniPrime E, UniPrime E/CKLE2022-07-06
2067861625175335K220960BruxZir Opaque Coloring LiquidEIH2022-06-29
2067861211320536K220816BruxZir NOWEIH2022-08-02
2067861391348795K213765Glidewell 3DP Denture Base ResinEBI2022-06-22
2067861893821386K213425BruxZir EstheticEIH2021-11-17
2067861892140059K211069EndSnorZ Sleep ApplianceLRK2021-10-26
2067861018241907K203706Dental Electric MotorEBW2022-01-13
2067861843750413K202003Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimLZA2021-02-24
2067861387495102K201683PMMA BlockEBG2020-11-03
2067861515745476K200131BruxZir SteelEIH2020-06-10
2067861045095990K191903BruxZir GT (Gum Tissue) ColorEIH2019-11-22
2067861663975339K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EVNHA2019-08-05
2067861849395894K183270Silent Nite slLRK2019-07-17
2067861065127590K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemNHA2017-06-06
2067861677259319K162537CAD/CAMouflage Milling BlockEBF2016-11-16
2067861246585209K160979Inclusive AbutmentsNHA2016-11-04
2067861044713628K160425CAD/CAMouflage Milling BockEBF2016-07-15
2067861339958549K153099INCLUSIVE TAPERED IMPLANT SYSTEMDZE2016-05-23
2067861190199827K152600Collagen Dental Wound DressingsKGN2016-06-23
2067861797984858K151798Inclusive Titanium Abutments compatible with: Straumann synOcta Implant SystemNHA2015-11-16
2067861473748152K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemNHA2015-10-07
2067861104733431K150872BruxZir Anterior Milling BlanksEIH2015-07-02
2067861141215833K143515Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace ImplantsNHA2015-10-01
2067861969075339K143353Hahn Tapered Implant SystemDZE2015-04-02
2067861395733582K143330BruxZir AnteriorEIH2014-12-15
2067862001857826K142118INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAENHA2014-11-25
2067861791303299K142115INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANTNHA2014-11-13
2067862029141739K141923INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/XNHA2015-01-06
2067861308738211K141909COLLAGEN DENTAL MEMBRANE - CONFORMABLE PPNPL2014-11-05
2067861106906837K141887OBSIDIAN PRESS (ALL CERAMIC AND POM)EIH2014-11-06
2067861274603436K141788OBSIDIAN MILLING BLOCKSEIH2014-08-20
2067861664726067K141421PMMA BLOCKEBG2015-02-09
2067862060208079K141211INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTSNHA2014-10-22
2067861729850127K133850CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)EBF2014-06-04
2067861029070525K133071ELASTIC IMPRESSION MATERIALELW2014-05-28
2067861136124469K132393CERCOM II CEMENTEMA2014-03-14
2067861900852777K130924BRUXZIR SHADEDEIH2013-05-16
2067861741380813K130604UNIVERSAL PASTE STAINS AND GLAZEEIH2013-09-12
2067861542888617K121688MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEMNHA2012-10-12
2067861710044343K121406INCLUSIVE TAPERED IMPLANT SYSTEMDZE2013-02-22
2067861438037522K121391INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTSNHA2012-12-10
2067861013849167K121365THERMOFORMED MOUTHGUARDSMQC2012-11-20
2067861428941363K120858IMPLANT BARNHA2012-12-06
2067861012725713K110600COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGENNPL2011-07-29
2067861105085690K100993INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTSNHA2010-12-28
2067861335198146K100932INCLUSIVE MINI IMPLANTDZE2010-12-27
2067861270871097K100781OBSIDIAN CERAMIC BLOCKSEIH2010-06-21
2067861572331034K083742SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIXLYC2009-02-12
2067861769897420K083480INCLUSIVE ZIRCONIA ABUTMENT BLANKSNHA2009-05-05
2067861136872600K083192INCLUSIVE TITANIUM ABUTMENT BLANKSNHA2009-03-04
2067861054721010K080025LED.L, LED.M, LED.G, LED.BEBZ2008-03-19
2067861610871571K073217INCLUSIVE IMPLANT ABUTMENTSNHA2008-05-14
2067862020694217K062951TAP III ANTI-SNORING DEVICELRK2006-12-12
2067861742047477K061732TAP-TLRK2006-07-12
2067861992242820K060388TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENTLRK2006-05-17
2067861747046824K060104PRISMATIK CLINICAL ZIRCONIAEIH2006-03-15
2067861687942411K030859NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAINEIH2003-03-27
2067861989004925K012767S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALELW2001-11-01
2067861820672173K011431RESIN CEMEMA2001-06-11
2067861088495345K000983CERAMIX PORCELAIN SYSTEMEIH2000-08-26
2067861295684619
2067861698993494
2067861937053908
2067861979110797
2067861995329535
2067861206174148
3287121206174148
2067861291536863
2067861315337594
2067861412564491

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA352025-11-18
EIH262025-02-25
DZE102016-05-23
LRK92023-11-14
EBF52016-11-16
ELW52014-05-28
EBI32025-06-25
MQC22023-02-17
EBG22020-11-03
NPL22014-11-05
EMA22014-03-14
KCT12025-03-21
PNP12024-03-14
KLE12022-07-06
EBW12022-01-13
LZA12021-02-24
KGN12016-06-23
LYC12009-02-12
EBZ12008-03-19

PMN#

55 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next