Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1718476

FEI Number

1718476

Entity Name

RMO

City/State/Country

Franklin, IN, US

Establishment Address

2165 Earlywood Drive, Franklin, IN 46131, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RMO (Owner Number: 10078580)

Owner / Operator Contact Address

2165 Earlywood Drive, Franklin, IN 46131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TruLock Conditioner FITZGERALD X-RAY HOLDING UNIT Patient Relief Wax Schweickhardt/Apex Series Ligating pliers / ligature removal / ligature director/Tucker Truform Dual Top RMO Impression Tray Dual Top and Orthonia endosseous dental implant tools Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock Schweickhardt band adapter/SEATERS Ortho-Jel Alginate Flashmax P4 Light Curing Pen and Flashmax Accessories Bendaloy Titanium, Niti Coil Spring; Elgiloy; FLI Copper and FLI Aesthetic; Orthonol, Thermaloy Plus Thermaloy Nickel Titanium Wire; RMLocks, Hooks, Other Accessories; SWLRF Wires; TRU-CHROME Stainless Steel RMO Separators Space Maintainer, Lingual Arch, Bimetric Arch, Preformed Lingual Mouthguard Schweickhardt/Apex Series Pliers ELASTIC SEPARATORS; Elastic Thread; Elastics; Energy Chain; RMO ELASTOMERIC LIGATURES; Rotation Wedge Zero Corrector Rapid palatal expander Quad Helix, Multi-Action Appliance, Palatal Appliance, Adapter Cheek Retractor RMO Mouthgaurd Kussick Orthopedic Incline; Kussick Tongue Retrainer TruLock BRUSH and Sticks Bridging wire; Silver Solder Truform

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2020-11-11
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2020-11-11
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2023-08-03
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2020-11-11
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2020-10-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-10-28
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2020-11-11
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-11-17
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2020-11-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-11-09
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2020-11-11
ELW	Material, Impression	Dental	Class 2	872.3660	2020-11-17
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2023-08-07
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2020-11-09
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2020-11-17
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2023-08-03
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2020-11-17
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2020-11-11
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2020-11-09
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-11-11
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2020-11-17
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2020-11-17
KXR	Applicator, Resin	Dental	Class 1	872.3140	2020-11-17
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2020-11-11
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2020-10-29

Official Correspondent

Brandon Bernacchi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RMO

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1718476. Last updated year: 2026. Please use registration number 1718476 when referencing this establishment in official correspondence.