PDT, Inc.
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6…
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette – Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16″) (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm)
Who Else Makes It
Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 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 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| 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 |
| Dongguan Shun King Company Limited | Dongguan | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EAX |
| Device type | Mirror, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-20 |
| Record revised | 2025-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T055-6 Double-Sided PrecisionReflect HD Mirror Twelve Pack | In distribution | |
| T050-3 #5 PrecisionReflect HD Mirror (15/16″) Three Pack | In distribution | |
| T050 #5 Front Surface Mirror, Cone Socket, (15/16′) | In distribution | |
| R927 PDT Tissue Grafting Kit | In distribution | |
| T055 Double-sided #5 HD Mirror Cone-socket | In distribution | |
| R922 PDT Oral Surgery Kit | In distribution | |
| T051-3 #4 PrecisionReflect HD Mirror (7/8″) Three Pack | In distribution | |
| T051-12 #4 PrecisionReflect HD Mirror (7/8″) Three Pack | In distribution | |
| R933 PDT Cement (Crown Seating) Kit | In distribution | |
| R972 RDH Exam Kit | In distribution | |
| T051 #4 Mirror (7/8″) | In distribution | |
| R981 Cement Kit | In distribution | |
| T055-3 Double-Sided PrecisionReflect HD Mirror Three Packket | In distribution | |
| T050-12 #5 PrecisionReflect HD Mirror (15/16″) Twelve Pack | In distribution | |
| R979 DDS Exam Kit | In distribution | |
| R937 PDT Total Restorative Kit | In distribution | |
| R971 Just Be Nice Hygiene Kit | In distribution | |
| R970 Just Be Nice Hygiene Kit with Cassette | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E. Hahnenkratt GmbH | E. Hahnenkratt Gmbh | 118 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 108 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 86 |
| Crystal HD® Mouth Mirrors | Zirc Dental Products, Inc. | 65 |
| Sklar® | Sklar Corporation | 60 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 59 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 43 |
| Osung MND | Osung MND Co., Ltd. | 39 |
| Mouth Mirror Handle | Zirc Dental Products, Inc. | 33 |
| Jedmed | Jedmed Instrument Company | 31 |
| Plasdent | Plasdent Corp. | 30 |
| Henry Schein | Henry Schein, Inc. | 27 |
Showing 12 of 205. All products under Mirror, Mouth
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.