FDA.reportPublic FDA data

Royal Dental Lab

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040861833004086183Royal Dental Lab1N2026-01-01F/1, 2, 3, 5, 6, Building 2, No. 4 West Area Shangxue Industry Park, Bantian, Longgang Shenzhen Guangdong CN 518129
30062244713006224471ROYAL DENTAL LABS, INC.1Y2026-01-01597-599 INDUSTRIAL DR CARMEL IN US 46032
30085177103008517710ROYAL DENTAL LABORATORY LIMITED1N2020-04-25610 Nathan Road, Rooms 1318-20, 13F Hollywood Plaza Kowloon Mongkok Not Applicable HK 518112

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
06973051080014NA - This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.+86075589501914fiona@china-dental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
621381572492550K192767Clear AlignerNXC2020-01-08
2135121059409345K061732TAP-TLRK2006-07-12
621381112281263K061732TAP-TLRK2006-07-12
2135121200673965
621381272896876
621381308838402
2135121319434128
2135121347318106
621381347887380
621381594444577
621381676995023
621381682099358
2135121727582980
621381806714559
621381862721119
2135121874164918
2135121915597633
2135121932529257
2135121952374208
2135122005201284
621382043183609
621382067908896
621381027908159

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC22020-01-08
LRK22006-07-12

PMN#

GUDID#