Edenta
Round pin medium - without sleeve
4manufacturers in China registered for this device type
155catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Hunan (1). 2 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 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Edenta Etablissement, LI |
|---|---|
| FDA product code | EBL |
| Device type | Pin, Retentive And Splinting, And Accessory Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3740 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-03 |
| Record revised | 2024-04-26 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6317-10 | 10 | In distribution | |
| 6012-10 | 10 | In distribution | |
| 6209SO | In distribution | ||
| 6411-10 | 10 | In distribution | |
| 6308SO | In distribution | ||
| 6309SO | In distribution | ||
| 2004 | In distribution | ||
| PIN0220-1000 | 1,000 | In distribution | |
| 2028SO | In distribution | ||
| 6207SO | In distribution | ||
| 2009SO | In distribution | ||
| 6152-3 | 3 | In distribution | |
| PIN0210-1000 | 1,000 | In distribution | |
| 6507SO | In distribution | ||
| PIN0203-1000 | 1,000 | In distribution | |
| 2031SO | In distribution | ||
| 6415-10 | 10 | In distribution | |
| 2029SO | In distribution | ||
| 6010-10 | 10 | In distribution | |
| 6210-10 | 10 | In distribution | |
| 6302SO | In distribution | ||
| 2025SO | In distribution | ||
| PIN0190-1000 | 1,000 | In distribution | |
| 6502SO | In distribution | ||
| 6204SO | In distribution | ||
| 6414-10 | 10 | In distribution | |
| 6303SO | In distribution | ||
| 6028-3 | 3 | In distribution | |
| 6402SO | In distribution | ||
| 2006SO | In distribution | ||
| 6314-10 | 10 | In distribution | |
| 6509SO | In distribution | ||
| 6024-3 | 3 | In distribution | |
| 6514-10 | 10 | In distribution | |
| 6002SO | In distribution | ||
| PIN0222-1000 | 1,000 | In distribution | |
| 6407SO | In distribution | ||
| 6027-3 | 3 | In distribution | |
| 6013-10 | 10 | In distribution | |
| 6021-3 | 3 | In distribution | |
| 2014-6 | 6 | In distribution | |
| 6310-10 | 10 | In distribution | |
| 2010SO | In distribution | ||
| 6315-10 | 10 | In distribution | |
| PIN0216-1000 | 1,000 | In distribution | |
| 6103SO | In distribution | ||
| 2016SO | In distribution | ||
| 6409SO | In distribution | ||
| 6217-10 | 10 | In distribution | |
| 6214-10 | 10 | In distribution | |
| 2026SO | In distribution | ||
| 2037-10 | 10 | In distribution | |
| 6404SO | In distribution | ||
| K900445-1000 | 1,000 | In distribution | |
| 6307SO | In distribution | ||
| 6305SO | In distribution | ||
| 6150-3 | 3 | In distribution | |
| 6104SO | In distribution | ||
| 2012SO | In distribution | ||
| 6517-10 | 10 | In distribution | |
| 6405SO | In distribution | ||
| 6313-10 | 10 | In distribution | |
| 6113-10 | 10 | In distribution | |
| 6206SO | In distribution | ||
| 6316-10 | 10 | In distribution | |
| 2007SO | In distribution | ||
| 2008-100 | 100 | In distribution | |
| 6352-3 | 3 | In distribution | |
| 6026-3 | 3 | In distribution | |
| 6508SO | In distribution | ||
| 6115-10 | 10 | In distribution | |
| 2027-100 | 100 | In distribution | |
| 6110-10 | 10 | In distribution | |
| 6304SO | In distribution | ||
| 6212-10 | 10 | In distribution | |
| PIN0212-1000 | 1,000 | In distribution | |
| 6111-10 | 10 | In distribution | |
| 6515-10 | 10 | In distribution | |
| 6213-10 | 10 | In distribution | |
| 6311-10 | 10 | In distribution | |
| 6106SO | In distribution | ||
| 6306SO | In distribution | ||
| 6011-10 | 10 | In distribution | |
| 6410-10 | 10 | In distribution | |
| 2038-10 | 10 | In distribution | |
| 6417-10 | 10 | In distribution | |
| 2015SO | In distribution | ||
| 2023SO | In distribution | ||
| 2018SO | In distribution | ||
| 6112-10 | 10 | In distribution | |
| 6511-10 | 10 | In distribution | |
| 6025-3 | 3 | In distribution | |
| PIN0219-1000 | 1,000 | In distribution | |
| K900446-1000 | 1,000 | In distribution | |
| 6512-10 | 10 | In distribution | |
| 6205SO | In distribution | ||
| PIN0215-1000 | 1,000 | In distribution | |
| 6510-10 | 10 | In distribution | |
| PIN0200-1000 | 1,000 | In distribution | |
| 6453-3 | 3 | In distribution | |
| 6353-3 | 3 | In distribution | |
| 6412-10 | 10 | In distribution | |
| 6208SO | In distribution | ||
| 6023-3 | 3 | In distribution | |
| 6203SO | In distribution | ||
| 2022SO | In distribution | ||
| 6452-3 | 3 | In distribution | |
| 6450-3 | 3 | In distribution | |
| 6413-10 | 10 | In distribution | |
| 6020-3 | 3 | In distribution | |
| PIN0217-1000 | 1,000 | In distribution | |
| 2020SO | In distribution | ||
| 6351-3 | 3 | In distribution | |
| 6503SO | In distribution | ||
| 6005SO | In distribution | ||
| 6211-10 | 10 | In distribution | |
| 2024SO | In distribution | ||
| 6006SO | In distribution | ||
| PIN0213-1000 | 1,000 | In distribution | |
| 6403SO | In distribution | ||
| 6151-3 | 3 | In distribution | |
| 6312-10 | 10 | In distribution | |
| 6505SO | In distribution | ||
| 6107SO | In distribution | ||
| 6216-10 | 10 | In distribution | |
| 2003-6 | 6 | In distribution | |
| 6102SO | In distribution | ||
| 6014-10 | 10 | In distribution | |
| 6406SO | In distribution | ||
| 6215-10 | 10 | In distribution | |
| PIN0211-1000 | 1,000 | In distribution | |
| 6350-3 | 3 | In distribution | |
| 2017SO | In distribution | ||
| 2021SO | In distribution | ||
| 2013SO | In distribution | ||
| 6022-3 | 3 | In distribution | |
| 6029-3 | 3 | In distribution | |
| 6202SO | In distribution | ||
| 2011-100 | 100 | In distribution | |
| 6451-3 | 3 | In distribution | |
| 6516-10 | 10 | In distribution | |
| 2019-6 | 6 | In distribution | |
| PIN0209-1000 | 1,000 | In distribution | |
| 6105SO | In distribution | ||
| 6506SO | In distribution | ||
| PIN0218-1000 | 1,000 | In distribution | |
| 2030-100 | 100 | In distribution | |
| 6416-10 | 10 | In distribution | |
| K900447-1000 | 1,000 | In distribution | |
| 6513-10 | 10 | In distribution | |
| 6504SO | In distribution | ||
| 6114-10 | 10 | In distribution | |
| 6408SO | In distribution | ||
| 6003SO | In distribution | ||
| 6004SO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blue Sky Bio, LLC | Blue SKY BIO, LLC | 571 |
| TMS | Coltene/Whaledent Gmbh & Co. KG | 46 |
| Code Rings | Pulpdent Corporation | 31 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 19 |
| rematitan® | Dentaurum GmbH & Co. KG | 16 |
| Stabilok | Fairfax Medical Products Ltd | 8 |
| Pin, Retentive And Splinting, And Accessory Instruments | Dentaurum GmbH & Co. KG | 6 |
| Bondent | Coltene/Whaledent Gmbh & Co. KG | 6 |
| Core Forms | Pulpdent Corporation | 5 |
| SRH3427LBlue Sky Bio, LLC | Blue SKY BIO, LLC | 5 |
| Max | Coltene/Whaledent Gmbh & Co. KG | 4 |
| Biotem | Biotem Co., Ltd. | 3 |
Showing 12 of 62. All products under Pin, Retentive And Splinting, And Accessory Instruments
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.