Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2029005

FEI Number

1000160570

Entity Name

ARCH Medical Solutions - Escondido LLC

City/State/Country

ESCONDIDO, CA, US

Establishment Address

950 Borra Place, ESCONDIDO, CA 92029, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARCH Medical Solutions - Escondido LLC (Owner Number: 9098779)

Owner / Operator Contact Address

950 BORRA PLACE, --, Escondido, CA 92029, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011028

PMA Number

N/A

All Registered Proprietary Names

Abutment, implant, dental, endosseous IMPLANT, ENDOSSEOUS, ROOT-FORM Orthopedic manual surgical instrument Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous IMPLANT, ENDOSSEOUS, ROOT-FORM PLATE, BONE Intervertebral fusion device with bone graft, cervical Abutment, implant, dental, endosseous Accessories, implant, dental, endosseous Abutment, implant, dental, endosseous Abutment, implant, dental, endosseous IMPLANT, ENDOSSEOUS, ROOT-FORM Pedicle screw spinal system, adolescent idiopathic scoliosis IMPLANT, ENDOSSEOUS, ROOT-FORM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-03-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-03-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-07-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-05-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-25
JEY	Plate, Bone	Dental	Class 2	872.4760	2012-12-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-07-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-04-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-03-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-03-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-04-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-25
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-07-08
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-07-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-07-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-25

Official Correspondent

Charles Green

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARCH Medical Solutions - Escondido LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2029005. Last updated year: 2026. Please use registration number 2029005 when referencing this establishment in official correspondence.