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Salvin Dental Specialties, Inc.

USA · Charlotte

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

75listed device types

Class I 56Class II 18Class III 0unclassified 1

plus 83 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class IV 1

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States83 registration records, 4 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: SALVIN DENTAL SPECIALTIES, LLC

FDA 510(k) clearances by year

12008 · K073342

12010 · K100182

12016 · K160493

12017 · K161857

FDA listed device types

showing 8 of 75

Gown, Surgical 1Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Screw, Fixation, Intraosseous 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Plate, Bone 1Suture, Nonabsorbable, Silk 1Suture, Absorbable, Natural 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K161857	Salvin Tenting Screw System	2017-04-28
US	K160493	Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm	2016-09-08
US	K100182	SALVIN DENTAL SPECIALTIES FIXATION SCREW	2010-05-10
CA	94035	RENOVIX	Class IV

Salvin Dental Specialties, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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