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ARROWHEAD DE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088176033008817603ARROWHEAD DE LLC1N2026-01-01401 Westpark Ct Ste 200 Peachtree City GA US 30269
10004045161000404516ARROWHEAD DENTAL INC.1N2020-04-2511170 S State St Sandy UT US 84070

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
00855967006004ARROW-LOK - ARROW-LOK 3.5-3.5mm / Length 13mm, Straight901-853-4366INFO@ArrowheadDevices.com
00855967006011ARROW-LOK - ARROW-LOK 3.5-3.5mm / Length 16mm, Straight901-853-4366INFO@ArrowheadDevices.com
00855967006028ARROW-LOK - ARROW-LOK 2.5-3.5mm / Length 19mm, Angled901-853-4359INFO@ArrowheadDevices.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1579611836411715K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCELRK1997-09-29
1224351020667298K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT2019-05-14
1224351840315191K180539Deformity Analysis and Correction Software (DACS) and InstrumentationOSN2018-08-13
1579611778143328K170053Meridian PMLRK2017-11-28
1224351689651347K162032Arrowhead Mini-Rail FixatorKTT2017-02-21
1579611322814955K151295Biodenta Customized Abutment - TitaniumNHA2015-12-01
1224351703082216K112675ARROW-LOK DIGITAL SYSTEMHTY2011-12-12
1224351305237002K100926ARROWHEAD FIXATION DEVICEHTY2010-10-29
1579611737400790

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HTY42011-12-12
KTT22019-05-14
LRK22017-11-28
OSN12018-08-13
NHA12015-12-01

PMN#

GUDID#

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