Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2086043

FEI Number

3000719964

Entity Name

PAC-DENT INC.

City/State/Country

Brea, CA, US

Establishment Address

670 Endeavor Cir, Brea, CA 92821, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Pac-Dent Inc. (Owner Number: 10056434)

Owner / Operator Contact Address

670 Endeavor Cir, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pac-Dent Disposable Tray, Tooth Whitening Pac-Dent SG JS Dental ProAngle ProMate Freestyle Pro ProMateEZ-Q Quick Disconnect Coupler AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct ProMate EZ-Q Quick Disconnect Hygiene Handpiece ACCLEAN ERGO PROPHY ANGLE LF AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct AntiSplatr Disposable Prophy Angles ProMate EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler Rodin 3D Resin Try-In Isolation clothing Armor Premium Disposable Plastic Non-Surgical Isolation Gowns Disposable Protective Coverall Safety Suit Disposable Plastic Isolation Gown Disposable Button-Up Isolation Gown Reusable Non-Surgical Isolation Gowns Disposable Non-Woven Isolation Gowns Digital Thermometer JS Dental JS Dental Rodin Luting Cement Rodin Envision veneer cement PJ-01 ProJect Composite Dispensing Gun Rodin 3D Ceramic Nanohybrid Resin Rodin Sculpture 2 RapidCeram iMatrix Clear Rodin InteCem Intermediate Restorative Material Rodin 3D Resin Clear Bite Spl Rodin TruModel AntiSplatr Disposable Prophy Angles JS Dental FINGER SPREADER LENTULO PSTE FILL SPIRAL PASTE FILL G-FILE METAL Bur Block Magnetic PacBond One OptiComp Promin Dental Desensitizing Gel 341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml 341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case 341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case COMPOSITE SPATULAS PLASTIC iBrite Teeth Whitening Gel PacTemp Automix Releasing Agent PacTemp Automix NE Releasing Agent EzAim X-Ray Positioning System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2017-12-21
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-07-24
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2017-12-21
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-12-21
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2019-01-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2017-12-11
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2024-06-25
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2024-06-25
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2022-09-16
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-02
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-12-21
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2017-12-21
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2017-12-21
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-12-21
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2021-05-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-01
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2017-12-14
EKM	Gutta-Percha	Dental	Class 1	872.3850	2017-12-14
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2017-12-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-02-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2017-12-14
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2017-12-21
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2017-12-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-09-04
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2017-12-14
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2017-12-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-09-16
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2017-12-21
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2017-12-29
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2023-09-20
KXR	Applicator, Resin	Dental	Class 1	872.3140	2018-06-22
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2022-09-16
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2017-12-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-06-25
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-06-25
LZB	Finger Cot	General Hospital	Class 1	880.6250	2020-12-15
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2017-12-14
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2018-09-13
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2017-12-21
EFN	Cotton, Roll	Dental	Class 1	872.6050	2017-12-11
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2017-12-21
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2023-04-14
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2017-12-11
JET	Pick, Massaging	Dental	Class 1	872.6650	2017-12-21
ELW	Material, Impression	Dental	Class 2	872.3660	2017-12-14
ELR	Post, Root Canal	Dental	Class 1	872.3810	2017-12-14
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2017-12-14
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2017-12-11
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2017-12-14
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2017-12-21
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2017-12-21
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2022-04-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-12-14
EFH	Paper, Articulation	Dental	Class 1	872.6140	2017-12-11
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-10-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-08-15
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2018-09-13
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-12-21
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2017-12-14
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2024-06-27
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2024-06-27
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-10-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-12-21
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2017-12-21
EBP	Reliner, Denture, Over The Counter	Dental	Class 2	872.3560	2024-05-07
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2017-12-21
DZM	Needle, Dental	Dental	Class 1	872.4730	2017-12-08
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-01-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2017-12-11
EHB	Collimator, X-Ray	Dental	Class 1	872.1840	2017-12-11
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-12-21
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2022-08-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-12-14
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2017-12-14

Official Correspondent

Nikki Huynh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pac-Dent Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004046477	Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, CN
3015491448	iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - 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-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - 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-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - 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 2086043. Last updated year: 2026. Please use registration number 2086043 when referencing this establishment in official correspondence.