Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085199

FEI Number

1000160732

Entity Name

H & H CO.

City/State/Country

Hayden, ID, US

Establishment Address

11888 N Tracey Rd, Hayden, ID 83835, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

W.H. Holden Inc. DBA H & H Company (Owner Number: 9010035)

Owner / Operator Contact Address

11888 N. TRACEY RD, --, Hayden, ID 83835, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCALERS OPERATING LIGHT FORCEPS CLAMP WASHTRAY 1/2 PERIODONTIC RAMUS SEPARATOR NEEDLE HOLDER LAMINA SPREADER IRRIGATOR SINUS DENTAL HAND PROBE PLIERS OSTEOTOME RIDGE EXPANSION OSTEOTOME PERIODONTIC KNIFE MEASURING TAPE MALLET REMOVER DRILL INTRAORAL FORCEPS IMPLANT YANKAUER SUCTION TUBE FILE BURS SPECULUM SURGICAL TISSUE SCISSORS DENTAL ELEVATOR LIGHT FIBER OPTIC BONE CHISELS SINUS TREPHINES FILE BONE PARTICLE COLLECTOR RETRACTOR CURETTE CONDENSERS FORCEPS RONGEUR SURGICAL FORCEPS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2003-07-08
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2007-05-07
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-05-07
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2007-05-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-11-10
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2003-07-08
EJY	Pliers, Operative	Dental	Class 1	872.4565	2016-11-10
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2016-11-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-11-10
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2007-05-07
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2007-05-07
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2003-07-08
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2003-07-08
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2003-07-08
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2003-07-08
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2003-07-08
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2016-11-10
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2003-07-08
EIS	Remover, Crown	Dental	Class 1	872.4565	2007-05-07
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2007-05-07
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2003-07-08
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2003-07-08
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2016-11-10
EMR	File, Periodontic	Dental	Class 1	872.4565	2003-07-08
EJL	Bur, Dental	Dental	Class 1	872.3240	2007-05-07
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2003-07-08
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2007-05-07
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2003-07-08
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2007-05-07
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2003-07-08
KBF	Trephine, Sinus	Ear, Nose, Throat	Class 1	874.4420	2007-05-07
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2003-07-08
MXP	Bone Particle Collector	Ear, Nose, Throat	Class 1	874.4800	2003-07-08
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2007-05-07
EKE	Curette, Operative	Dental	Class 1	872.4565	2003-07-08
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2007-05-07
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2003-07-08
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2007-05-07

Official Correspondent

Jared Cullum

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

W.H. Holden Inc. DBA H & H Company

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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085199. Last updated year: 2026. Please use registration number 2085199 when referencing this establishment in official correspondence.