Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044038

FEI Number

3001027751

Entity Name

ADVANCED HEALTHCARE LTD.

City/State/Country

TONBRIDGE Kent, GB

Establishment Address

UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY, TONBRIDGE Kent TN11 8JU, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADVANCED HEALTHCARE LTD. (Owner Number: 9005225)

Owner / Operator Contact Address

UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY, TONBRIDGE, GB-KEN TN11 8JU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020376

PMA Number

N/A

All Registered Proprietary Names

EUGENOL CEMENT AHL GENERIC REINFORCED ZINC OXIDE Tempit E + Thin Tempit E (Centrix) Temporary Dental Cement / Temp Luti AHL Direct DIA (Diamond) Paste Vivid OrthoLute Cement Glass Ionomer Silver Reinforced (Al Universal L/C Composite (Beautifil) Glass Ionomer Luting Cement Radiopa GlasIonomer Cement CX-Plus Zinc Polycaboxylate Cements Polycarboxylate Cement A59-0042 Vivid Total Bond SE A59-0044 Glass Ionomer Aesthetic Restorative

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-11-22
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	1998-01-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2008-02-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-11-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2013-12-16
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-22

Official Correspondent

Jeremy Clarke

US Agent Details

Tyler Ting Business: Rook Quality Systems Email: tyler.ting@rookqs.com Phone: (770) 8330116

Related Public Records

Same Entity

ADVANCED HEALTHCARE LTD.

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
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.

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3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044038. Last updated year: 2026. Please use registration number 8044038 when referencing this establishment in official correspondence.