Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012101632

FEI Number

3012101632

Entity Name

SKY DENT Corp for dental trading

City/State/Country

New York, NY, US

Establishment Address

280 Madison Ave, # 912, New York, NY 10016, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

SKY DENT Corp for dental trading (Owner Number: 10050378)

Owner / Operator Contact Address

280 Madison Ave, #912, New York, NY 10016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SKY DENT NERVE BROACH - 1DERFUL NERVE BROACH SKY DENT PROPHY PASTE CUPS - 1DERFUL PROPHY PASTE CUPS SKY DENT ORTHODONTIC TUBE - 1DERFUL ORTHODONTIC TUBE SKY DENT KIDS CROWNS - 1DERFUL KIDS CROWNS SKY DENT SPREADER - 1DERFUL SPREADER SKY DENT ORTHODONTIC BAND - 1DERFUL ORTHODONTIC BAND SKY DENT ARTICULATING PAPER - 1DERFUL ARTICULATING PAPER SKY DENT - 1DERFUL: HEDSTROM, K-FILE, C-FILE, GO, BRAVO, CHALLENGER, NU, DUO, DISCOVERY, RE-DO. SKY DENT REAMER - 1DERFUL REAMER SKY DENT BURS, 1DERFUL BURS SKY DENT ORTHODONTIC BRACKET - 1DERFUL ORTHODONTIC BRACKET SKY DENT - 1DERFUL : GATES DRILL, PEESO REAMER, PASTE FILLER. SKY DENT TEMPORARY FILLING - 1DERFUL TEMPORARY FILLING SKY DENT PLUGGER - 1DERFUL PLUGGER SKY DENT ORTHODONTIC WIRE - 1DERFUL ORTHODONTIC WIRE SKY DENT GEL - 1DERFUL GEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2015-12-11
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2019-12-05
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2016-02-12
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2021-11-09
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2015-12-11
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2016-02-12
EFH	Paper, Articulation	Dental	Class 1	872.6140	2016-02-12
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2015-12-11
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2015-12-11
EJL	Bur, Dental	Dental	Class 1	872.3240	2019-05-12
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-02-12
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2015-12-11
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2019-04-15
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2015-12-11
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2016-02-12
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2021-09-07

Official Correspondent

Mohamad Al Kassab

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SKY DENT Corp for dental trading

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3008370577	SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTD	Shanghai, CN
3002692886	MANI, INC. (HEAD OFFICE)	UTSUNOMIYA Tochigi, JP
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012101632. Last updated year: 2026. Please use registration number 3012101632 when referencing this establishment in official correspondence.