Dentech
Deciduous Clamp set with cassette, Glossy (Rubber Dam Clamp Board with 8pcs clamps in a cassette)
4manufacturers in China registered for this device type
262catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Hebei (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | Dentech Corp., Japan |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01019067 | In distribution | |
| 01014004 | In distribution | |
| 01019917 | In distribution | |
| 01014030 | In distribution | |
| 01012026 | In distribution | |
| 01019901 | In distribution | |
| 01040070 | In distribution | |
| 01014022 | In distribution | |
| 01014026 | In distribution | |
| 01013001 | In distribution | |
| 01019504 | In distribution | |
| 01020008 | In distribution | |
| 01019010 | In distribution | |
| 01012506 | In distribution | |
| 01019030 | In distribution | |
| 01012914 | In distribution | |
| 01014005 | In distribution | |
| 01014056 | In distribution | |
| 01019908 | In distribution | |
| 01012205 | In distribution | |
| 01012992 | In distribution | |
| 01014025 | In distribution | |
| 01019503 | In distribution | |
| 01012207 | In distribution | |
| 01015001 | In distribution | |
| 01012044 | In distribution | |
| 01019200 | In distribution | |
| 01041071 | In distribution | |
| 01014139 | In distribution | |
| 01012029 | In distribution | |
| 01012022 | In distribution | |
| 01014209 | In distribution | |
| 01019501 | In distribution | |
| 01014051 | In distribution | |
| 01019914 | In distribution | |
| 01040020 | In distribution | |
| 01014702 | In distribution | |
| 01012009 | In distribution | |
| 01019029 | In distribution | |
| 01014009 | In distribution | |
| 01014210 | In distribution | |
| 01041060 | In distribution | |
| 01012209 | In distribution | |
| 01019907 | In distribution | |
| 50710700 | In distribution | |
| 01019028 | In distribution | |
| 01019008 | In distribution | |
| 01012200 | In distribution | |
| 01014903 | In distribution | |
| 50550001 | In distribution | |
| 01019210 | In distribution | |
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| 01012031 | In distribution | |
| 01012051 | In distribution | |
| 01014043 | In distribution | |
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| 01019090 | In distribution | |
| 01012908 | In distribution | |
| 01020002 | In distribution | |
| 50030000 | In distribution | |
| 01012025 | In distribution | |
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| 01012208 | In distribution | |
| 01012913 | In distribution | |
| 01014027 | In distribution | |
| 01012030 | In distribution | |
| 01012501 | In distribution | |
| 01014001 | In distribution | |
| 01012043 | In distribution | |
| 01019002 | In distribution | |
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| 01014090 | In distribution | |
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| 01019913 | In distribution | |
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| 50550020 | In distribution | |
| 50550000 | In distribution | |
| 01040050 | In distribution | |
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| 01019005 | In distribution | |
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| 50550030 | In distribution | |
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| 01012014 | In distribution | |
| 01012201 | In distribution | |
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| 01012998 | In distribution | |
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| 50550011 | In distribution | |
| 01019026 | In distribution | |
| 01014008 | In distribution | |
| 01014912 | In distribution | |
| 01014006 | In distribution | |
| 01012056 | In distribution | |
| 01015007 | In distribution | |
| 01019003 | In distribution | |
| 01015005 | In distribution | |
| 01012008 | In distribution | |
| 01019998 | In distribution | |
| 01019042 | In distribution | |
| 01040081 | In distribution | |
| 01012139 | In distribution | |
| 01019138 | In distribution | |
| 01012027 | In distribution | |
| 01014211 | In distribution | |
| 01019502 | In distribution | |
| 01012067 | In distribution | |
| 01019912 | In distribution | |
| 01012002 | In distribution | |
| 01020003 | In distribution | |
| 01019022 | In distribution | |
| 01020004 | In distribution | |
| 01014010 | In distribution | |
| 01012503 | In distribution | |
| 01019212 | In distribution | |
| 01012090 | In distribution | |
| 01019001 | In distribution | |
| 01019015 | In distribution | |
| 01012138 | In distribution | |
| 01019009 | In distribution | |
| 01012206 | In distribution | |
| 01012701 | In distribution | |
| 50580002 | In distribution | |
| 01014028 | In distribution | |
| 01040060 | In distribution | |
| 01013002 | In distribution | |
| 01012007 | In distribution | |
| 50580001 | In distribution | |
| 01014067 | In distribution | |
| 01012502 | In distribution |
Showing 250 of 262 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 127 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 109 |
| Hysolate | DENT4YOU AG | 59 |
| Power Dental U.S.A., Inc. | Power Dental U.S.A. Inc. | 51 |
| Benco | Benco Dental Supply Co. | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| Power Dental USA | Power Dental U.S.A. Inc. | 18 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 15 |
| Osung MND | Osung MND Co., Ltd. | 13 |
| Burkhart Dental Supply | Burkhart Dental Supply Co., THE | 11 |
| Nivo | B. ALI Impex | 7 |
| Rubber Dam Clamps | HU-Friedy MFG Co., LLC | 6 |
Showing 12 of 114. All products under Clamp, Rubber Dam
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-21 | Class II | Component design/selection | Removing parts for safety reasons due to possible breakage. | 87,842 UNITS | 2023-01-12 |
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.