PDT, Inc.
Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin…
Kit Includes: T015E-F FlipTop™ Cassette ‘E’ – Fixed Rack 15 w/Std Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin Composite R363S 113 Straight Serrated Cord Packer R375 Mixing Spatula/Applicator R386 38-39 Excavator T050 #5 Front Surface Mirror, Cone-Socket, (15/16′) T040 Tweezers COLLEGE T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T319 Bur Block T800 IRIS Scissors, curved
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| medmix China Ltd | Shanghai | Shanghai | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-30 |
| Record revised | 2022-05-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R362S 113 Off Angle Serrated Cord Packer | In distribution | |
| R148 MacFarlane 6-7 TC | In distribution | |
| R362 113 Off Angle Cord Packer | In distribution | |
| R374 #24 Spatula | In distribution | |
| R149 MacFarlane 8-9 TC | In distribution | |
| R363 113 Straight Cord Packer | In distribution | |
| R935 PDT Crown & Bridge Kit | In distribution | |
| R909 – PDT Wallet 3 Pack – Doctor | In distribution | |
| R363S 113 Straight Serrated Cord Packer | In distribution | |
| R375 Mixing Spatula/Applicator | In distribution | |
| R980 Crown and Bridge Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMDental | LM-Dental | 936 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 544 |
| Instruments, Dental Hand | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 307 |
| Power Dental USA | Power Dental U.S.A. Inc. | 209 |
| Supremo Instrumentos | Andre Gregate Braga Instrumentos Ltda | 95 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 92 |
| Diamodent | Diamodent | 81 |
| Stoma® | Storz AM Mark Gmbh | 80 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 77 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 67 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 58 |
Showing 12 of 1,362. All products under Instruments, Dental Hand
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.