Dental Device Guide
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Manufacturer registered with FDA

Black & Black Surgical Inc

Tucker, GA, United States. Lists 3 dental device types with FDA across 1 registered establishment.

FDA owner/operator9097380Repacker / relabelerSpecification developer
Device types listed
3
Brands and models
3
510(k) clearances
0as applicant
Markets registered in
13208 registrations outside the US
Establishments
1United States

Registered in 13 markets

Where regulators' registries name Black & Black Surgical Inc as the manufacturer or the registration holder of a device.

All markets
United States: 3 device types listedCanada: 63 registrationsAustralia: 40 registrationsUnited Kingdom: 32 registrationsSouth Korea: 21 registrationsSaudi Arabia: 16 registrationsBrazil: 13 registrationsTaiwan: 11 registrationsEuropean Union: 6 registrationsCosta Rica: 2 registrationsIsrael: 2 registrationsColombia: 1 registrationsSerbia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerBlack & Black Surgical Inc3 device types—Below
CanadaHealth CanadaRegistration holderBLACK AND BLACK SURGICAL632015–2023Pure Global AI
AustraliaTGAManufacturerBlack & Black Surgical Inc402018–2018Pure Global AI
United KingdomMHRAManufacturerBlack and Black Surgical32—Pure Global AI
South KoreaMFDSManufacturerBlack & Black Surgical, Inc.Black & Black Surgical, Inc · BLACK & BLACK SURGICAL, INC. · +1212010–2026Pure Global AI
Saudi ArabiaSFDAManufacturerBlack & Black Surgical. Inc16—Pure Global AI
BrazilANVISAManufacturerBLACK & BLACK SURGICAL, INC.132018–2026Pure Global AI
TaiwanTFDAManufacturerBLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL112008–2024Pure Global AI
European UnionEUDAMEDManufacturerBlack & Black Surgical Inc.6—Pure Global AI
Costa RicaMinisterio de SaludManufacturerBlack & Black Surgical, Inc2—Pure Global AI
IsraelAMARManufacturerBlack & Black Surgical2—Pure Global AI
ColombiaINVIMAManufacturerBLACK & BLACK SURGICAL INC.1—Pure Global AI
SerbiaALIMSManufacturerBlack & Black Surgical, Inc.12024–2024Pure 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 Black & Black Surgical Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Headlight LightEBA · Class 1Dental operating lightsLister
Headlight
2013
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsMaker
SCISSOR
2017
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsMaker
Rongeur
2013

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
BLACK & BLACK SURGICAL, INC.FDA reg. 3006142527Tucker, GA, United StatesRepacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9097380). 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.