Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007210751

FEI Number

3007210751

Entity Name

DENTSCARE LTDA

City/State/Country

Joinville Santa Catarina, BR

Establishment Address

Av. Edgar Nelson Meister, 474, Joinville Santa Catarina 89219-501, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dentscare Ltda (Owner Number: 10055009)

Owner / Operator Contact Address

Av. Edgar Nelson Meister, 474, Joinville, BR-SC 89219-501, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210231

PMA Number

N/A

All Registered Proprietary Names

3007210751 Diamond R Diamond Master Diamond Excel Diamond ACI & ACII Diamond Excel Ultrafine Ambar APS Ambar Universal APS 10055009 Opus Bulk Fill Flow APS Opus Bulk Fill APS Allcem Core Allcem Whitepost DC Drill Whitepost DC-E Drill Whitepost System DC Drill Whitepost System DC-E Drill Whitepost System DC Fit TOP DAM 1G TOP DAM 2G Orthocem Ortho Bite Arcflex Whitepost DC-E Whitepost DC Whitepost System DC FIT Intro Whitepost System DC Intro Whitepost System DC FIT Refill Whitepost System DC-E Kit Whitepost System DC Kit Whitepost System DC-E Refill Whitepost System DC Refill Whitepost System DC-E Intro Whitepost System DC-E Refill Mix Whitepost System DC Refill Mix Whitepost System DC FIT Refill Mix Allcem Core Mixing tips Allcem Veneer APS Allcem Veneer Try-in Vittra APS Unique

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POW	Crown And Bridge, Long-Term Temporary, Resin	Dental	Class 2	872.3770	2025-03-20
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2025-03-20
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2018-08-07
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-12-18
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2024-11-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-11-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-09-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-11-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-11-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-02-02
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-07-16
EIE	Dam, Rubber	Dental	Class 1	872.6300	2017-06-30
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2020-08-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-08-17
EIG	Retractor, All Types	Dental	Class 1	872.4565	2017-06-27
ELR	Post, Root Canal	Dental	Class 1	872.3810	2018-06-12
KXR	Applicator, Resin	Dental	Class 1	872.3140	2020-02-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-02
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-11-03

Official Correspondent

Friedrich Mittelstadt

US Agent Details

Rodrigo Abreu Business: United Regulatory & Logistics LLC Email: rabreu@unitedregulatory.com Phone: (786) 2667900

Related Public Records

Same Entity

Dentscare Ltda

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
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
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

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-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.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007210751. Last updated year: 2026. Please use registration number 3007210751 when referencing this establishment in official correspondence.