PDT, Inc.
Kit includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer…
Kit includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009C-D FlipTop™ Cassette ‘C’ – Double Rack 18 T050 #5 Front Surface Mirror, Cone-Socket, (15/16′)
3manufacturers in China registered for this device type
120catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EMS |
| Device type | Curette, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-01 |
| Record revised | 2020-12-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2020-09-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R077 Younger-Good 7-8 | In distribution | |
| R007R Gracey 13-14 ER Mini Rigid | In distribution | |
| R152 O’Hehir New Millennium 7-8 Debridement Curette | In distribution | |
| R985 Rev B Andy RDH Student Kits | In distribution | |
| R020 Gracey 5-6 | In distribution | |
| R004R Gracey 7-8 ER Mini Rigid | In distribution | |
| R028R Gracey 13-14 Rigid | In distribution | |
| R150 O’Hehir New Millennium 1-2 Debridement Curette | In distribution | |
| R022 Gracey 7-8 | In distribution | |
| R030R Gracey 15-16 Rigid | In distribution | |
| R044 Gracey 15-16 ER | In distribution | |
| R907FE A Battrell™ Quadrant Gracey Duo Pack (First Edition) | In distribution | |
| R005 Gracey 9-10 ER Mini | In distribution | |
| R158 O’Hehir New Millennium 17-18 Debridement Curette | In distribution | |
| R034R Gracey 11-14 Rigid | In distribution | |
| R099 23A (Rounded Toe) | In distribution | |
| R144 Queen of Hearts | In distribution | |
| R024 Gracey 9-10 | In distribution | |
| R088 Langer 17-18 Mini | In distribution | |
| R064D Columbia 13-14 DULL | In distribution | |
| R042R Gracey 11-12 ER Rigid | In distribution | |
| R010 Gracey 1-2 ER Mini | In distribution | |
| R003 Gracey 5-6 ER Mini | In distribution | |
| R973 Pediatric Prophy Kit | In distribution | |
| R157 O’Hehir New Millennium 15-16 Debridement Curette | In distribution | |
| R081 Langer 5-6 | In distribution | |
| R026 Gracey 11-12 | In distribution | |
| R159 O’Hehir New Millennium 19-20 Debridement Curette | In distribution | |
| R005R Gracey 9-10 ER Mini Rigid | In distribution | |
| R028 Gracey 13-14 | In distribution | |
| R008 Gracey 15-16 ER Mini | In distribution | |
| R087 Langer 17-18 | In distribution | |
| R032R Gracey 17-18 Rigid | In distribution | |
| R080 Langer 3-4 | In distribution | |
| R060 Barnhart 1-2 | In distribution | |
| R064 Columbia 13-14 | In distribution | |
| R061 Barnhart 5-6 | In distribution | |
| R067 Columbia 4L-4R | In distribution | |
| R978 Gross Debridement Kit | In distribution | |
| R066 Columbia 2L-2R | In distribution | |
| R090C H5-L5 | In distribution | |
| R016 Gracey 1-2 | In distribution | |
| R695 Gracey 11-12 Titanium Extended Reach Micro Mini | In distribution | |
| R156 O’Hehir New Millennium 13-14 Debridement Curette | In distribution | |
| R985 Andy RDH Student Kit | In distribution | |
| R977 Gingival Inflammation Kit | In distribution | |
| R680 Wingrove™ L3-4 Titanium Implant | In distribution | |
| R039 Battrell Quadrant Gracey 16-17 | In distribution | |
| R028C Gracey 13-14 | In distribution | |
| R020R Gracey 5-6 Rigid | In distribution | |
| R043R Gracey 13-14 ER Rigid | In distribution | |
| R070 McCalls 13S-14S | In distribution | |
| R975 SRP Kit | In distribution | |
| R006 Gracey 11-12 ER Mini | In distribution | |
| R046 Gracey 11-14 ER | In distribution | |
| R013 Gracey 11-12 ER Micro Mini | In distribution | |
| R037 | In distribution | |
| R661 Wingrove™ B5-6 Titanium Implant | In distribution | |
| R084 Langer 5-6 Mini | In distribution | |
| R153 O’Hehir New Millennium 9-10 Debridement Curette | In distribution | |
| R026R Gracey 11-12 Rigid | In distribution | |
| R696 Gracey 13-14 Titanium Extended Reach Micro Mini | In distribution | |
| R043 Gracey 13-14 ER | In distribution | |
| R151 O’Hehir New Millennium 1-2 Extended Reach Debridement Curette | In distribution | |
| R008R Gracey 15-16 ER Mini Rigid | In distribution | |
| R001R Gracey 00 Rigid | In distribution | |
| R083 Langer 3-4 Mini | In distribution | |
| R036 Gracey 12-13 | In distribution | |
| R047 Gracey 12-13 ER | In distribution | |
| R004 Gracey 7-8 ER Mini | In distribution | |
| R069 McCalls 13-14 | In distribution | |
| R030 Gracey 15-16 | In distribution | |
| R007 Gracey 13-14 ER Mini | In distribution | |
| R006R Gracey 11-12 ER Mini Rigid | In distribution | |
| R052 Gracey 3-4 ER | In distribution | |
| R016R Gracey 1-2 Rigid | In distribution | |
| R694 Gracey 1-2 Titanium Extended Reach Micro Mini | In distribution | |
| R079 Langer 1-2 | In distribution | |
| AU061 Barnhart 5-6 | In distribution | |
| AU026 Gracey 11/12 | In distribution | |
| R012 Gracey 7-8 ER Micro Mini | In distribution | |
| R089 Mini Me | In distribution | |
| R028D Amazing Gracey 13-14 DULL | In distribution | |
| R038 Battrell Quadrant Gracey 15-18 | In distribution | |
| R022R Gracey 7-8 Rigid | In distribution | |
| R030D Amazing Gracey 15-16 DULL | In distribution | |
| R974 Adult Prophy Kit | In distribution | |
| R014 Gracey 13-14 ER Micro Mini | In distribution | |
| R042 Gracey 11-12 ER | In distribution | |
| AU028 Gracey 13-14 | In distribution | |
| R071 McCalls 17-18 | In distribution | |
| R032 Gracey 17-18 | In distribution | |
| R060R Barnhart 1-2 Rigid | In distribution | |
| R009 Gracey 17-18 ER Mini | In distribution | |
| R907 A Battrell™ Quadrant Gracey Duo Pack | In distribution | |
| R144C Queen of Hearts | In distribution | |
| R036R Gracey 12-13 Rigid | In distribution | |
| R072 McCalls 17S-18S | In distribution | |
| R018 Gracey 3-4 | In distribution | |
| R034 Gracey 11-14 | In distribution | |
| R082 Langer 1-2 Mini | In distribution | |
| R076 Rules 3-4 | In distribution | |
| R976 Perio Maintenance Kit | In distribution | |
| R011 Gracey 1-2 ER Micro Mini | In distribution | |
| Gracey 00 | In distribution | |
| Gracey 11-12 ER Mini | Withdrawn | |
| Gracey 9-10 ER Mini Rigid | Withdrawn | |
| Gracey 17-18 ER Mini | Withdrawn | |
| Gracey 11-12 ER Mini Rigid | Withdrawn | |
| Gracey 15-16 ER Mini Rigid | Withdrawn | |
| Gracey 1-2 ER Mini | Withdrawn | |
| Gracey 00 | Withdrawn | |
| Gracey 7-8 ER Mini Rigid | Withdrawn | |
| Gracey 00 Rigid | Withdrawn | |
| Gracey 15-16 ER Mini | Withdrawn | |
| Gracey 9-10 ER Mini | Withdrawn | |
| Gracey 13-14 ER Mini Rigid | Withdrawn | |
| Gracey 5-6 ER Mini | Withdrawn | |
| Gracey 13-14 ER Mini | Withdrawn | |
| Gracey 7-8 ER Mini | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 1,276 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 1,032 |
| American Eagle Instruments | American Eagle Instruments | 681 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 301 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 185 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 145 |
| Stoma® | Storz AM Mark Gmbh | 121 |
| Henry Schein | Henry Schein, Inc. | 112 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 108 |
| Pomee | Pomee Corporation | 69 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 63 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 62 |
Showing 12 of 321. All products under Curette, 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.