Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010493

FEI Number

1344

Entity Name

KAVO DENTAL GMBH

City/State/Country

BIBERACH Baden-Wurttemberg, DE

Establishment Address

BISMARCKRING 39, BIBERACH Baden-Wurttemberg 88400, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KaVo Dental GmbH (Owner Number: 10042139)

Owner / Operator Contact Address

Bismarckring 39, Biberach, DE-BW 88400, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130560

PMA Number

N/A

All Registered Proprietary Names

ELECTROmatic PM/PC - 111.1900 ELECTROmatic T2M - S - 113311 ELECTROmatic M - S - 112.8537 ELECTROmatic TM - 111.2100 ELECTROmatic C - S - 112.8539 ELECTROmatic PC - L - 112.8544 ELECTROmatic PC - S - 112.8543 ELECTROmatic M/C - 111.1800 ELECTROmatic M - L - 112.8538 ELECTROmatic TMC - S - 112.8549 ELECTROmatic TM - S - 112.8545 ELECTROmatic PM - L - 112.8542 ELECTROmatic TMM - L - 112.8548 ELECTROmatic PM - S - 112.8541 ELECTROmatic TMM - S - 112.8547 ELECTROmatic C - L - 112.8540 ELECTROmatic TM - L - 112.8546 ELECTROmatic TMC - L - 112.8550 ELECTROmatic TMM/TMC - 111.2600 elements e-motion - 113.3300 INTRA LUX Motor KL 703 LED - 107150 handpiece tubing 1.830 A-dec - 114.7770 COMFORTdrive 200 XD - 100.5500 Handpiece tubing 1.370 A-dec - 114.5690 Orion Dual Motor Control - 111.7169 0.535.5250 - INTRAmatic 181 M 0.535.5260 - INTRA 181 K 20 000 R.P.M. 0.535.5210 - INTRA L-LUX 181 L 0.535.5200 - INTRA-L-MOTOR 181 H 107.1700 - GENTLEmini LUX 4500BR 101.8776 - INTRA LUX Motor KL 701 107.3600 - EXPERTtorque Mini LUX E677 L 107.3580 - GENTLEpower LUX 25 LPR 0.535.6200 - INTRAflex LUX2 2329 LN 103.9882 - Trio-Pack 181P/181P/181P 107.5530 - EXPERTmatic E15 L 104.4503 - INTRAmatic 19 ES 101.7522 - POWERtorque 646 B 107.2400 - GENTLEsilence LUX 6500 BR 0.535.6220 - INTRAflex LUX2 2313 LN 106800 - EXPERTtorque E675 LMW 107.5540 - EXPERTmatic E20 L 103.1107 - INTRAmatic 20 E 0.553820 - COMPACTtorque 636 CP 103.6976 - INTRAmatic 31 E 108.1825 - INTRA Mini Kopf L52 108.1828 - INTRA EVA Kopf L61 G 108.1832 - INTRA Kopf L67 101.7454 - GENTLEpower LUX 29 LP 104.4456 - INTRA Kopf L80 103.6977 - INTRAmatic 10 E 108.1822 - INTRA Endo Kopf L3 107.5531 - EXPERTmatic E15 C 0.535.6190 - INTRAflex LUX2 2307 LN 103.2278 - PROPHYwiz 181 P 0.535.6210 - INTRAflex LUX2 2325 LN 101.7452 - GENTLEpower LUX 7 LP 106780 - GENTLEsilence LUX gold 8000 BR 106.6400 - EXPERTtorque E675 L 104.6403 - INTRAmatic 19 E 104.6401 - INTRAmatic 80 E 103.1109 - INTRAmatic 31 ES 107.5560 - EXPERTmatic E10 C 107.5550 - EXPERTmatic E25 L 0.535.6180 - INTRAflex LUX2 2320 LN 104.5380 - INTRAmatic 23 ES 101.5660 - GENTLEpower LUX 10 LP 103.1108 - INTRAmatic 14 E 108.4999 - EXPERTmatic E61 C 106.9200 - EXPERTtorque E679 L 108.1823 - INTRA Endo Kopf L3 Y 107.5551 - EXPERTmatic E25 C 107.5541 - EXPERTmatic E20 C 101.7453 - GENTLEpower LUX 20 LP 108.1829 - INTRA EVA Kopf L61 R 108.4998 - EXPERTmatic E31 C 108.1830 - INTRA Kopf L62 108.1835 - INTRA Micro Kopf L22 108.1824 - INTRA Prophy Kopf L31 108.1826 - INTRA Endo Kopf L53 108.1834 - INTRA Kopf L68 B 108.1831 - INTRA Kopf L66 B 108.1833 - INTRA Kopf L68 107.1700 - MASTERtorque Mini LUX M4500 L 108.7800 - MASTERtorque LUX M8900 L 301.3400 - MASTERtorque Mini LUX M8700 LK 301000 - MASTERtorque Mini LUX M8700 L 111.2330 - MASTERtorque Mini Kids-Edition en 301600 - MASTERtorque Mini LUX M8700 LS 301.2200 - MASTERtorque Mini LUX M8700 LY 107.7100 - MASTERtorque LUX M9000 L COLOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2017-02-22
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-10-24
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

Crystal Bialek Business: KaVo Dental Technologies, LLC Email: crystal.bialek@kavo.com Phone: (704) 2886058

Related Public Records

Same Entity

KaVo Dental GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003637274	KAVO DENTAL GMBH	WARTHAUSEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17

Similar Registrations

Registration Number	Establishment Name	Location
3014683120	JMU DENTAL, INC	Fullerton, CA, US
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US
3009768364	Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, CN
9611253	NAKANISHI INC.	Kanuma Tochigi, JP
1054713	TOYO MEDICAL CO.	Doral, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010493. Last updated year: 2026. Please use registration number 8010493 when referencing this establishment in official correspondence.