Dental Device Guide
Add your company

Manufacturer registered with FDA

B. Braun Medical Industries Sdn. Bhd

PENANG, Malaysia. Lists 25 dental device types with FDA across 1 registered establishment.

FDA owner/operator8040308Contract manufacturer
Device types listed
25
Brands and models
25
510(k) clearances
0as applicant
Markets registered in
7721 registrations outside the US
Establishments
1Malaysia

Registered in 7 markets

Where regulators' registries name B. Braun Medical Industries Sdn. Bhd as the manufacturer or the registration holder of a device.

All markets
United States: 25 device types listedMalaysia: 453 registrationsSouth Korea: 108 registrationsColombia: 92 registrationsTaiwan: 58 registrationsCosta Rica: 9 registrationsBrazil: 1 registrations
RegisteredHome: MalaysiaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerB. Braun Medical Industries Sdn. Bhd25 device types—Below
MalaysiaMDARegistration holderB. BRAUN MEDICAL INDUSTRIES SDN. BHD.B. BRAUN MEDICAL INDUSTRIES SDN BHD4532021–2027Pure Global AI
South KoreaMFDSManufacturerB. Braun Medical Industries Sdn. Bhd.B.Braun Medical Industries Sdn. Bhd. · B.Braun Medical Industries Sdn. Bhd · +21081998–2026Pure Global AI
ColombiaINVIMAManufacturerB. BRAUN MEDICAL INDUSTRIES SDN.BHDB. BRAUN MEDICAL INDUSTRIES SDN. BHD · B. BRAUN MEDICAL INDUSTRIES SDN. BHD. · +292—Pure Global AI
TaiwanTFDAManufacturerB. BRAUN MEDICAL INDUSTRIES SDN. BHD.B. BRAUN MEDICAL INDUSTRIES SDN BHD · B. Braun Medical Industries Sdn. Bhd.581990–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerB. Braun Medical Industries Sdn. BhdB. Braun Medical Industries Sdn. Bhd. · B.Braun Medical Industries Sdn. Bhd.9—Pure Global AI
BrazilANVISAManufacturerB. BRAUN MEDICAL INDUSTRIES SDN BHD12014–2014Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What B. Braun Medical Industries Sdn. Bhd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsMaker
Aesculap
2020
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
Aesculap
2020
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker
Aesculap
2022
Articulation Paper ForcepsEFK · Class 1Dental hand instrumentsMaker
Aesculap
2020
Dental Dressing ForcepsEFL · Class 1Dental hand instrumentsMaker
Forceps
2012
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker
Aesculap
2020
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
Retractor
2012
Dental Wax CarverEIK · Class 1Dental hand instrumentsMaker
Aesculap
2020
Crown RemoverEIS · Class 1Dental hand instrumentsMaker
Aesculap
2020
Periodontic ProbeEIX · Class 1Dental hand instrumentsMaker
Periodontic Probe
2020
Dental Plastic Filling InstrumentEIY · Class 1Dental hand instrumentsMaker
Aesculap
2020
Dental Instrument HandleEJB · Class 1Dental hand instrumentsMaker
Handle
2012
Operative ExplorerEKB · Class 1Dental hand instrumentsMaker
Aesculap
2020
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsMaker
Operative Excavator
2020
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsMaker
Aesculap
2020
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsMaker
Aesculap
2025
Operative BurnisherEKJ · Class 1Dental hand instrumentsMaker
Aesculap
2020
Endodontic Root Canal PluggerEKR · Class 1Dental hand instrumentsMaker
Aesculap
2020
Surgical HemostatEMD · Class 1Dental hand instrumentsMaker
Hemostat
2012
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsMaker
Forceps
2012
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker
Rongeur Forceps
2020
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsMaker
Surgical Dental Elevator
2020
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsMaker
Aesculap
2020
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker
Scaler
2012
Periodontic KnifeEMO · Class 1Dental hand instrumentsMaker
Periodontic Knife
2020

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.FDA reg. 9612086PENANG Pulau Pinang, MalaysiaContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8040308). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.