PDT, Inc.
Kit Containing: R138T - Montana Jack Titanium R696 - Amazing Gracey 13-14 Titanium Extended Reach Micro Mini R630 - Pineyro Arch Ti1 R631 - Pineyro Arch Ti2 R632 - Pineyro Arch Ti3 R633 -…
Kit Containing: R138T – Montana Jack Titanium R696 – Amazing Gracey 13-14 Titanium Extended Reach Micro Mini R630 – Pineyro Arch Ti1 R631 – Pineyro Arch Ti2 R632 – Pineyro Arch Ti3 R633 – Pineyro Arch Ti4 R661 – Wingrove B 5-6 Titanium Implant R680 – Wingrove L 3-4 Titanium Implant R693 – Wingrove N128 Blunt-Langer 5 Mini Titanium Implant T216 – EasyView UNC12 Probe T061 – Diamond Head Ceramic Stone E-Z Jett Cassette 10-Place
34manufacturers in China registered for this device type
67catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| 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 | 2024-07-10 (version 3) |
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 |
| Distribution end date | 2020-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R125 J34-35 | In distribution | |
| R135C 204S | In distribution | |
| R091 Neb 128-L5 | In distribution | |
| R138 Montana Jack Scaler | In distribution | |
| R093 N128-L5 Mini | In distribution | |
| R915 PDT SRP C Kit | In distribution | |
| R633 Pineyro ArchTM Ti 4 | In distribution | |
| R913 PDT I Dream of Hygiene™ Kit | In distribution | |
| R110C H6-H7 | In distribution | |
| R630 Pineyro ArchTM Ti 1 | In distribution | |
| R693 Wingrove™ N128 Blunt-Langer 5 Mini Titanium Implant | In distribution | |
| R111D H5-33 DULL | In distribution | |
| R905 PDT3SAVER™ 3 | In distribution | |
| R138T Montana Jack Blunt Titanium | In distribution | |
| R121 MacFarlane 0-1 | In distribution | |
| R138R Montana Jack Scaler Rigid | In distribution | |
| R960 2024 Advent Calendar | In distribution | |
| R111 H5-33 | In distribution | |
| R098S 23 Slim (Pointed Toe) | In distribution | |
| R115 N128-33 Scaler | In distribution | |
| R129 Cattoni 107-108 | In distribution | |
| R133 204 IUFW | In distribution | |
| R092 H5-L5 Mini Scaler/Curette | In distribution | |
| R134 Micro Sickle | In distribution | |
| R908 – PDT Demo Wallet 3 Pack – Hygiene | In distribution | |
| R904 PDT3SAVER™ 2 | In distribution | |
| R136 204SD | In distribution | |
| R110 H6-7 | In distribution | |
| R130SC Jack B. Nimble Slim | In distribution | |
| R917 PDT Amazing Gracey™ Prophy Kit | In distribution | |
| R096 N1 | In distribution | |
| R117 Boge Precision Duo | In distribution | |
| R160 H5-OH2 ER | In distribution | |
| R130S Jack B. Nimble Scaler Slim | In distribution | |
| R631 Pineyro ArchTM Ti 2 | In distribution | |
| R098 23 (Pointed Toe) | In distribution | |
| R138BC PDT Montana Jack Scaler BC | In distribution | |
| R113 U15-33 Scaler | In distribution | |
| R138BCR | In distribution | |
| R110D H6-7 DULL | In distribution | |
| R632 Pineyro ArchTM Ti 3 | In distribution | |
| R090 H5-L5 Scaler/Curette | In distribution | |
| AU135 204S | In distribution | |
| R135 204S | In distribution | |
| R932 Ultimate Implant Kit | In distribution | |
| R903 PDT3SAVER™ 1 | In distribution | |
| R114 Neb 128 Scaler | In distribution | |
| R098MB | In distribution | |
| R916 PDT SRP Kit | In distribution | |
| R130C Jack B. Nimble | In distribution | |
| R960 2024 Advent Calendar | In distribution | |
| R931 Pineyro Arch™ Kit (Instruments Only) | In distribution | |
| R139 N2 | In distribution | |
| R900 Wingrove™ Titanium Implant Instrument “Go-To” Set | In distribution | |
| R142 220 | In distribution | |
| R132 JB Scaler | In distribution | |
| AU110 H6-7 | In distribution | |
| R138-25 25th Anniversary Montana Jack® | In distribution | |
| R122 MacFarlane 2-3 | In distribution | |
| R116 SE Neb 128 Scaler | In distribution | |
| R138C Montana Jack | In distribution | |
| R119 N135 | In distribution | |
| AU138 Ouback Jack | In distribution | |
| R130 Jack B. Nimble Scaler | In distribution | |
| Montana 4-5 Scaler | In distribution | |
| R118 Morse 0-00 | In distribution | |
| J34-35 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| American Eagle Instruments | American Eagle Instruments | 269 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Osung MND | Osung MND Co., Ltd. | 102 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
| J & J Instruments | J & J Instruments, LLC | 56 |
Showing 12 of 216. All products under Scaler, Periodontic
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.