Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014615644

FEI Number

3014615644

Entity Name

HEXA DENTAL

City/State/Country

Commerce, CA, US

Establishment Address

5211 E. Washington Blv. #2-201, Commerce, CA 90040, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

HEXA Dental (Owner Number: 10059459)

Owner / Operator Contact Address

5211 E. Washington Blv. #2-201, Commerce, CA 90040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K860633

PMA Number

N/A

All Registered Proprietary Names

HEXA Hexa Freeze Hexa Composite Hexa Hexa Bonding

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	2023-03-03
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-07-02
ELW	Material, Impression	Dental	Class 2	872.3660	2020-09-17
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-09-18
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2020-09-18
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2020-09-18
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2020-09-18
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-09-18
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2020-09-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-03-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-03-03
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-03-03
MLY	Vapocoolant Device	Unknown	Class U	N/A	2024-12-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-03-03
ELW	Material, Impression	Dental	Class 2	872.3660	2023-09-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-02-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-03-28
ELW	Material, Impression	Dental	Class 2	872.3660	2020-09-17
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-09-18
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-09-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-01-28
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2023-09-18
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2023-09-19

Official Correspondent

Faraz Rad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEXA Dental

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-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014615644. Last updated year: 2026. Please use registration number 3014615644 when referencing this establishment in official correspondence.