Dental › SurgicalScrew, Fixation, Intraosseous

Level ONE CMF

Screw, Maxdrive, MMF, Drill Free, Wide THD, 46* Flute, Stainless Steel Astm F138

Registry build 21.09.26
3manufacturers in China registered for this device type
71catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZL
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Dentalmaster (Xiamen) Medical Technology Co., Ltd. Xiamen Fujian Manufacturer 1

Record

Regulatory record for Level ONE CMF
Listed by KLS-Martin L.P., United States
FDA product code DZL
Device type Screw, Fixation, Intraosseous
Device class Class 2
Regulation 21 CFR 872.4880
Establishment Specification developer, Manufacturer
Record published 2016-03-24
Record revised 2024-06-19 (version 11)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2021-04-20

Catalogue Numbers

Catalogue numbers for Level ONE CMF
Catalogue number Size Per pack Status
25-092-48-91 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-48-61 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-44-61 2.0 X 10 MM THD, TTL=14 MM In distribution
25-092-38-91 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-38-05 2.0 X 8 MM THD, TTL=12 MM 5 In distribution
25-096-12-91 2.0 X 12 MM, TTL=16 MM In distribution
99-580-28-03 2.0 X 8 MM, TTL=12 MM In distribution
25-092-08-09 2.0 X 8 MM THD, TTL=12 MM 5 In distribution
25-096-08-61 2.0 X 8 MM, TTL=12 MM In distribution
25-092-38-61 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-12-91 2.0 X 12 MM THD, TTL=16 MM In distribution
25-092-52-05 2.0 X 12 MM THD, TTL=16 MM 5 In distribution
99-580-28-01 2.0 X 8 MM, TTL=12 MM In distribution
25-096-08-05 2.0 X 8 MM, TTL=12 MM 5 In distribution
25-099-12-09 2.0 X 8 MM THD, TTL=12 MM 2 In distribution
50-089-14-09 2.0 X 19 MM In distribution
25-092-52-91 2.0 X 12 MM THD, TTL=16 MM In distribution
50-089-10-09 2.0 X 10 MM THD, TTL=15 MM In distribution
50-340-13-09 2.0 X 8 MM THD, TTL=13 MM In distribution
25-098-38-91 2.0 X 8 MM THD, TTL=12 MM In distribution
50-341-15-09 2.0 X 10 MM THD, TTL=15 MM In distribution
25-092-42-91 2.0 X 12 MM THD, TTL=16 MM In distribution
25-090-08-09 2.0 X 8 MM THD, TTL=12 MM 5 In distribution
50-089-12-61 2.0 X 12 MM THD, TTL=17 MM In distribution
25-090-08-91 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-44-91 2.0 X 10 MM THD, TTL=14 MM In distribution
25-096-12-61 2.0 X 12 MM, TTL=16 MM In distribution
01-300-05-91 2.0 X 10 MM THD, TTL=15 MM In distribution
25-090-12-09 2.0 X 12 MM THD, TTL=16 MM 5 In distribution
50-341-13-09 2.0 X 8 MM THD, TTL=13 MM In distribution
50-340-17-09 2.0 X 12 MM THD, TTL=17 MM In distribution
50-089-12-09 2.0 X 12 MM THD, TTL=17 MM In distribution
50-340-19-09 2.0 X 14 MM THD, TTL=19 MM In distribution
25-098-42-05 2.0 X 12 MM THD, TTL=16 MM 5 In distribution
25-092-08-61 2.0 X 8 MM THD, TTL=12 MM In distribution
25-092-12-09 2.0 X 12 MM THD, TTL=16 MM 5 In distribution
50-340-15-09 2.0 X 10 MM THD, TTL=15 MM In distribution
25-092-52-61 2.0 X 12 MM THD, TTL=16 MM In distribution
25-090-12-91 2.0 X 12 MM THD, TTL=16 MM In distribution
50-089-10-61 2.0 X 10 MM THD, TTL=15 MM In distribution
25-092-42-05 2.0 X 12 MM THD, TTL=16 MM 5 In distribution
99-580-28-04 2.0 X 12 MM, TTL=16 MM In distribution
25-092-12-61 2.0 X 12 MM THD, TTL=16 MM In distribution
01-300-04-91 2.0 X 8 MM THD, TTL=13 MM In distribution
25-098-42-91 2.0 X 12 MM THD, TTL=16 MM In distribution
25-092-08-91 2.0 X 8 MM THD, TTL=12 MM In distribution
25-096-12-05 2.0 X 12 MM, TTL=16 MM 5 In distribution
99-580-28-02 2.0 X 12 MM, TTL=16 MM In distribution
25-099-12-91 2.0 X 8 MM THD, TTL=12 MM In distribution
99-580-28-52 2.0 X 12 MM, TTL=16 MM 5 In distribution
25-092-44-05 2.0 X 10 MM THD, TTL=14 MM 5 In distribution
25-098-38-05 2.0 X 8 MM THD, TTL=12 MM 5 In distribution
25-092-42-61 2.0 X 12 MM THD, TTL=16 MM In distribution
25-092-48-05 2.0 X 8 MM THD, TTL=12 MM 5 In distribution
25-096-08-91 2.0 X 8 MM, TTL=12 MM In distribution
01-300-05-61 2.0 X 10 MM THD, TTL=15 MM In distribution
25-099-14-09 2.0 X 10 MM THD, TTL=14 MM 2 Withdrawn
25-090-12-61 2.0 X 12 MM THD, TTL=16 MM Withdrawn
99-580-28-51 2.0 X 8 MM, TTL=12 MM 5 Withdrawn
50-089-08-09 2.0 X 13 MM Withdrawn
25-098-42-61 2.0 X 12 MM THD, TTL=16 MM Withdrawn
25-099-14-91 2.0 X 10 MM THD, TTL=14 MM Withdrawn
01-300-04-61 2.0 X 8 MM THD, TTL=13 MM Withdrawn
50-089-12-91 2.0 X 12 MM THD, TTL=17 MM Withdrawn
99-580-28-53 2.0 X 8 MM, TTL=12 MM 5 Withdrawn
25-098-38-61 2.0 X 8 MM THD, TTL=12 MM Withdrawn
25-090-08-61 2.0 X 8 MM THD, TTL=12 MM Withdrawn
25-099-16-91 2.0 X 12 MM THD, TTL=16 MM Withdrawn
99-580-28-54 2.0 X 12 MM, TTL=16 MM 5 Withdrawn
50-089-10-91 2.0 X 10 MM THD, TTL=15 MM Withdrawn
25-099-16-09 2.0 X 12 MM THD, TTL=16 MM 2 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OsteoMed Osteomed 1,295
Faico CMF System Faico Medical, LLC 540
Neoface Neoortho Produtos Ortopédicos S/A 181
CMF Visionare Visionare LLC 155
Universal Mandible AXS Stryker Leibinger Gmbh & Co. KG 148
Tandry CMF Plate System Microware Precision Co., Ltd. 140
Screw, Fixation, Intraosseous Synthes Gmbh 132
MatrixMIDFACE Synthes Gmbh 65
PlusDrive Synthes Gmbh 52
Universal 2.0 MP AXS Stryker Leibinger Gmbh & Co. KG 51
MCI – Medical Concept Innovation, Inc. MCI Medical Concept Innovation Inc. 49
CMF Southern Medical (PTY) Ltd 37

Showing 12 of 92. All products under Screw, Fixation, Intraosseous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233721 2024-09-17
K083432 2009-03-31
K042573 2004-10-18
K980760 1999-12-21

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