Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1051614

FEI Number

1051614

Entity Name

PRACTICON, INC.

City/State/Country

Greenville, NC, US

Establishment Address

1112 SUGG PKWY., Greenville, NC 27834, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PRACTICON, INC. (Owner Number: 1051614)

Owner / Operator Contact Address

1112 SUGG PKWY., --, Greenville, NC 27834, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TTL Easy Size Loupes Practifilm Barrier Cling Sheets Acu-Tip Electrosurgical Cauterizing Instrument Lumindex 3 BFC UNIT DOSE SYRINGE BFC3 Powered Impression Gun HP Mixing Tips Ribbon Intraoral Tips Bliss Face Masks Giggle Monster Face Masks Practivalu Toothbrush NiceTouch Toothbrush SmileGoods Toothbrush Cool Cassette 2 Instrument Tray BurSafe Bur Holder Cool Cassette 1 Cool Cassette 2 Compartment Tray Bite DX Roetzer Posterior Packer Sculptor (PPS) Instrument Compo-Dots Compo-Dot Angles EndoBand Cushions Disposable Probe/Shepherd's Hook HAHN 360 PDL Extractor Instrument Disposable Exam Packs Pike Anesthetic Syringe PRACTICON LIGATURE TIES GlasSpan Dental Fiber Standard Non-Woven Sponge Premium Non-Woven Sponge Patient Relief Wax QUIKSheath Barriers SmileGoods Tongue Cleaners Plastic Tongue Cleaners Color Splash Saliva Ejectors Practicon Colorful HVE Tips Mirro-Vac VacGuard HVE Screen Tips ColorFlex Saliva Ejectors ECOtip HVE Tips Angle-Ease Color Tip Saliva Ejectors LockOn S/E Valve Tips WhisperSafe HVE Tips Dispos-Evac HVE Tip Dispos-Evac Aspirators Mirro-Vac 2 HVEZ Hose Adapter Lock-on Saliva Ejector Valves Multi-Tips HVE Tips Total-Comfort ColorFlex Soft Tip Aspirators Rainbow Saliva Ejectors Lock-On Saliva Ejector Valve Max-Vac Evacuator Tips Lock-On HVE Hose Adapter PractiTip A-W Syringe Tips Practicon Rainbow Disposable A/W Syringe Tips Practicon Onyx Disposable A/W Syinge Tips Practicon Clear Disposable A/W Syringe Tips Smilegoods Sonic Toothbrush Disposable Mouth Mirror Mirror Cotton Holders Nice Touch Mouth Mirrors Practicon Versagrip Mouth Mirrors Practicon Classic Disposable Mouth Mirrors Practicon Vibrant Disposable Mouth Mirrors Practicon Fog-Free Photo Mirror Kit Lumindex 3 Barrier Sleeves PlateMates PSP Protectors Soft-Prop E-Prop FlexiProp Reusable Mouth Prop Disposable E-Prop FlosSeas Floss Hands SmileGoods Dental Floss Mobile Floss Indifloss Giraffe Flossers Floss Holders Mint Floss Picks SDFLosser Smilegoods Floss Threaders Mobile Floss 2 SmileGoods 3-in-1 Flossers PractiShield Practicon 33G Dental Needle SmileGoods Aligner Chewies Smilegoods Aligner Remover Smilegoods Right-Bite Aligner Seaters Y Type Cheek Retractor C Type Winged Cheek Retractor C Type Cheek Retractor Lip Retractor GP Cut Replacement Tips GP Cut Gutta Percha Cutter Dr. Shwartzs Cap Trap Retainers SmileGoods PikPak Interproximal Cleaners Micro Tray Practicon Autoclavable Impression Tray Disposable Edentulous Trays ECOsply Biodegradable Impression Trays Paraband Practicon Sterilization Pouches PRACTIFILM BARRIER FILM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-16
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2020-08-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-09
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2018-05-11
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2016-01-14
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-12-30
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2015-06-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-02-03
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-02-03
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2018-10-29
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2023-08-18
ELS	Splint, Endodontic Stabilizing	Dental	Class 2	872.3890	2018-08-03
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-16
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2022-11-03
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2023-06-09
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2017-07-11
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2006-12-07
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2011-07-07
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-01-08
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2006-12-07
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2008-04-09
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2017-07-11
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2015-06-05
JES	Floss, Dental	Dental	Class 1	872.6390	2007-01-11
DZM	Needle, Dental	Dental	Class 1	872.4730	2003-10-06
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2022-11-03
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-05-18
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2023-06-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-07-22
JET	Pick, Massaging	Dental	Class 1	872.6650	2017-07-11
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2011-05-25
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2013-11-25
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-07-25
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-07-25
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2024-07-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRACTICON, INC.

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1051614. Last updated year: 2026. Please use registration number 1051614 when referencing this establishment in official correspondence.