NTI

NTI SuperFlex Perforated CS Diamond Disc

Registry build 21.09.26
7manufacturers in China registered for this device type
1,014catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DZP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Huizhou Videya Technology Co., Ltd. Huizhou Guangdong Manufacturer 18
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. Zhangzhou Henan Manufacturer 6

Record

Regulatory record for NTI
Listed by NTI-Kahla Gmbh, Rotary Dental Instruments, Germany
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-01-01
Record revised 2024-06-19 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
Packaging Pack of 5, pack of 2
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for NTI
Catalogue number Size Per pack Status
848L-014C-FG 5 In distribution
856-014TSC-FGM 5 In distribution
858-010C-FG 5 In distribution
836KR-012M-FG 5 In distribution
879K-012C-FG 5 In distribution
847-012M-FG 5 In distribution
837KR-014SC-FG 5 In distribution
852-010F-FG 5 In distribution
878-014TSC-FG 5 In distribution
863-012C-FG 5 In distribution
878K-021SC-FG 5 In distribution
G9005 In distribution
850L-018SC-FG 5 In distribution
999-021F-FG 5 In distribution
863-016C-FG 5 In distribution
852-012F-FG 5 In distribution
847-025M-HP 3 In distribution
878-012TSC-FG 5 In distribution
856-018TSC-FG 5 In distribution
G5113 In distribution
835KR-012C-FG 5 In distribution
132-008SF-FG 5 In distribution
846-012C-FG 5 In distribution
858-012F-FG 5 In distribution
379-018M-FG 5 In distribution
909-040F-FGK 5 In distribution
837-014C-FGM 5 In distribution
856-025M-FG 5 In distribution
KS2-FG 50 In distribution
863-016TSC-FG 5 In distribution
801-014F-FG 5 In distribution
392-016M-FGM 5 In distribution
807-016M-HP 3 In distribution
856-016C-FG 50 In distribution
859L-016SC-FG 5 In distribution
856L-014F-FG 5 In distribution
885-014SC-FG 5 In distribution
836-012C-FG 5 In distribution
844-016F/C-FG In distribution
858-018C-FG 5 In distribution
837-016TSC-FG 5 In distribution
877K-014SC-FG 50 In distribution
801-029C-HP 3 In distribution
368-023UF-FG 5 In distribution
368-016M-FG 5 In distribution
859-012F-FG 5 In distribution
850-016TSC-FG 5 In distribution
D911HF-220 In distribution
876K-012M-FG 5 In distribution
834-016M-FG In distribution
846-012M-FG 5 In distribution
856-014TSC-FG 5 In distribution
856L-014C-FG 5 In distribution
839-012M-FG 5 In distribution
801-025SC-FG 5 In distribution
835-014C-FG 5 In distribution
847-016C-FGM 5 In distribution
998-021F-FG 5 In distribution
878K-014SC-FG 50 In distribution
801-016SC-FG 5 In distribution
863-016SC-FG 5 In distribution
847-014F-FG 5 In distribution
856-016TSC-FG 5 In distribution
134-014F-FG 5 In distribution
822-008C-FG 5 In distribution
G8004 In distribution
828-030M-FG In distribution
847-014TSC-FG 5 In distribution
835KR-014C-FG 5 In distribution
D919-190-HP In distribution
855-014F-FG 5 In distribution
801-016C-FG 50 In distribution
862-014C-FG 50 In distribution
379-023M-FG 5 In distribution
888-012M-FG 5 In distribution
856-014M-FG 5 In distribution
368-023F-FG 50 In distribution
846-025TSC-FG 5 In distribution
877K-016C-FG 5 In distribution
837KR-012SC-FG 5 In distribution
909-037C-FGK 5 In distribution
848-018C-FG 5 In distribution
830-010M-FG 5 In distribution
855-025SC-FG 5 In distribution
806.104.505.514.220 In distribution
856L-018C-FG 5 In distribution
MADC06-009M-FG 5 In distribution
847-023SC-FG 5 In distribution
859L-016C-FG 5 In distribution
806.104.357.514.220 In distribution
859L-016M-FG 5 In distribution
840-014M-FG 5 In distribution
857-012C-FG 5 In distribution
379-014M-FG 5 In distribution
879SE-012F-FG 5 In distribution
886-014SC-FG 5 In distribution
D918-190-HP In distribution
KS2T-FG 5 In distribution
847KR-016M-FG 5 In distribution
878-012M-FG 5 In distribution
850-012F-FG 5 In distribution
878K-016F-FG 5 In distribution
863-012C-HP 3 In distribution
862-014C-FGM 5 In distribution
862-009M-FG 5 In distribution
835KR-014F-FG 5 In distribution
FS3-SF 10 In distribution
836-014M-FG 5 In distribution
845KR-018C-FG 5 In distribution
801-016F-FG 5 In distribution
884-012C-FG 5 In distribution
D911H-160 In distribution
856-012F-FG 5 In distribution
847KR-016SC-FGM 5 In distribution
885-012C-FG 5 In distribution
368-016C-FG 5 In distribution
856L-016C-FG 50 In distribution
878K-018F-FG 5 In distribution
KS1-FG 50 In distribution
801-035M-FG 5 In distribution
856-018SC-FGM 5 In distribution
836KR-014F-FG 5 In distribution
806.104.405.524.220 In distribution
899-027C-FG 5 In distribution
848-016F-FG 5 In distribution
855-025M-FG 5 In distribution
862-018C-FG 5 In distribution
863-014F-FG 5 In distribution
830-016M-FG 5 In distribution
842R-018M-HP 3 In distribution
877K-012M-FG 5 In distribution
879-012TSC-FG 5 In distribution
862-016M-FG 5 In distribution
878K-018TSC-FG 5 In distribution
856-012SC-FG 5 In distribution
878K-016C-FG 50 In distribution
846KR-016M-FG 5 In distribution
859-018F-HP 3 In distribution
836-014SC-FG 5 In distribution
862-010M-FG 5 In distribution
837KR-016TSC-FG 5 In distribution
813-012C-FG 5 In distribution
836KR-008M-FG 5 In distribution
837KR-010C-FG 5 In distribution
FS2-M 10 In distribution
859-018M-FG 5 In distribution
850-016SC-FG 50 In distribution
886-014F-FG 5 In distribution
G5115 In distribution
877K-018C-FG 5 In distribution
830-012C-FG 5 In distribution
877K-014TSC-FG 5 In distribution
D911HEF-190 In distribution
850W-018SC-FG 50 In distribution
881-014SC-FG 5 In distribution
805-014M-FG 5 In distribution
838-010C-FG 5 In distribution
845KR-016M-FG 5 In distribution
850-023C-FG 5 In distribution
KS7-FG 5 In distribution
862-012C-FG 5 In distribution
801-016C-FG 5 In distribution
FS3-MX 10 In distribution
837KR-014F-FG 5 In distribution
852-010M-FG 5 In distribution
878-012C-FGM 5 In distribution
813-016C-FG 5 In distribution
847-014C-FG 5 In distribution
849-016C-FG 5 In distribution
846-016F-FG 5 In distribution
806.104.505.504.160 In distribution
999-021M-FG 5 In distribution
885-010F-FG 5 In distribution
886-016C-FG 5 In distribution
883-010M-FG 5 In distribution
847KR-016SC-FG 50 In distribution
862-012TSC-FG 5 In distribution
858-014C-FG 5 In distribution
392-016M-FG 5 In distribution
N883-007 5 In distribution
863-010M-FG 5 In distribution
847-016SC-FGM 5 In distribution
878K-016TSC-FG 5 In distribution
859L-014M-FG 5 In distribution
KS3T-FG 5 In distribution
878K-014SC-FG 5 In distribution
837-010M-FG 5 In distribution
860-014F-FG 5 In distribution
850-016SC-FG 5 In distribution
837-010C-FG 5 In distribution
856-016M-FG 5 In distribution
801L-016C-FG 5 In distribution
805-018M-HP 3 In distribution
909-037M-FGK 5 In distribution
837-014C-FG 5 In distribution
877K-018TSC-FG 5 In distribution
G8002 In distribution
847-014M-FG 5 In distribution
850W-018M-FG 5 In distribution
848-016SC-FG 5 In distribution
861-012C-FG 5 In distribution
860-010M-FG 5 In distribution
909-040SC-FGK 50 In distribution
839-012F-FG 5 In distribution
806-014M-FG 5 In distribution
379-018C-FG 5 In distribution
879K-014C-FG 5 In distribution
859-012UF-FG 5 In distribution
846KR-016F-FG 5 In distribution
806.104.505.504.220 In distribution
368-023SF-FG 5 In distribution
889-009SF-FG 5 In distribution
835-009C-FG 5 In distribution
802-012C-FG 5 In distribution
879K-016TSC-FG 5 In distribution
878-010M-FG 5 In distribution
G5114-RA In distribution
856-021SC-FGM 5 In distribution
811-033TSC-FG 5 In distribution
805-009M-FG 5 In distribution
850-012C-FG 5 In distribution
379-023SF-FG 5 In distribution
830-009M-FG 5 In distribution
858-016SC-FG 5 In distribution
845KR-025M-FG 5 In distribution
G5111 In distribution
811-033M-FG 5 In distribution
379-016SC-FG 5 In distribution
986-026F-FG 5 In distribution
862-010UF-FG 5 In distribution
878-016C-FG 5 In distribution
879-012F-FG 5 In distribution
132-008F-FG 5 In distribution
850-010F-FG 5 In distribution
801-023M-FG 5 In distribution
G9008 In distribution
822-008M-FG 5 In distribution
852-037M-HP 3 In distribution
850L-016C-FG 5 In distribution
858-014SF-FG 5 In distribution
863-012C-FGM 5 In distribution
986-041SF-FG 5 In distribution
847-023C-FG 5 In distribution
849-025C-FG 5 In distribution
856-014SC-FGM 5 In distribution
801-025C-FG 5 In distribution
845KR-025C-FG 5 In distribution
835KR-008M-FG 5 In distribution
G5331 In distribution
849-010SF-FG 5 In distribution

Showing 250 of 300 catalogue numbers.

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Showing 12 of 366. All products under Instrument, Diamond, Dental

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer