510(k) K092231
- Device
- GEBDI TRIBOS 501
- Applicant
- GEBDI DENTAL-PRODUCTS GMBH
- 510(k) number
- K092231
- Product code
- ELM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-24
- Date received
- 2009-07-23
- Regulation
- 872.3590
- Classification name
- Denture, Plastic, Teeth
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS BISKUPSKI
- Address
- Industriestr 3a Engen Bawu DE 78234 78234
FDA Registration Numbers#
- 3030224946
- 3005176727
- 3011203516
- 3006942327
- 9612352
- 4565
- 3013538161
- 3012389497
- 3009161350
- 3026317445
- 3010348588
- 3023248501
- 3034729565
- 3003103749
- 3006459726
- 3016998377
- 9681531
- 3007740664
- 3014253211
- 3043648115
- 3021432364
- 3005665377
- 3016564992
- 3021023132
- 3024749697
- 3003929447
- 8010908
- 2424472
- 3003794907
- 3043303267
- 3039441248
- 3006610834
- 3006191485
- 3020052762
- 3010864832
- 3005895657
- 3004491043
- 3011500388
- 3008792854
- 3022519816
- 3011814610
- 3016117382
- 3004905070
- 8010019
- 3004362235
- 3004425647
- 3010656982
- 3003928050
- 3005974404
- 3014289665
- 3010245461
- 3002727993
- 1000303432
- 3023082366
- 2436918
- 3042623520
- 1000243214
- 3002808149
- 3006059056
- 3010872423
- 3005350578
- 3016986305
- 3015353992
- 3005904906
- 1000625496
- 3012453120
- 3012968498
- 3023346365
- 1000277456
- 1460656
- 3010253209
- 3009496224
- 3030154803
- 2244842
- 3015414875
- 3029507159
- 3008317118
- 3003120666
- 3009541709
Source Documents#
Other 510(k) Records For Product Code ELM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132984 | SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S | Ivoclar Vivadent, Inc. | 2014-01-14 |
| K122955 | DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM | Wright Health Group , Ltd. | 2013-03-01 |
| K122925 | NEW STETIC ARTIFICIAL TEETH | New Stetic | 2013-02-12 |
| K122852 | PHYSIOSTAR NFC | Candulor USA, Inc. | 2012-12-06 |
| K121749 | VERACIA | Shofu Dental Corporation | 2012-09-07 |
| K120404 | MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH | Merz Dental GmbH | 2012-05-21 |
| K120736 | SR PHONARES II | Ivoclar Vivadent, AG | 2012-05-14 |
| K113426 | VERACIA SA | Shofu Dental Corporation | 2012-02-08 |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | 2010-09-14 |
| K101029 | KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH | Huge Dental Material Co., Ltd. | 2010-08-16 |
| K093331 | SR PHONARES NHC | Ivoclar Vivadent, Inc. | 2010-01-28 |
| K070591 | REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH | Union Dental S.A./Unidesa.Odi | 2007-05-11 |
| K060720 | CURATIVE DENTAL ACRYLIC TEETH | Curative, LLC | 2006-08-25 |
| K061337 | WIEDENT ESTETIC | Xpdent Corp | 2006-06-07 |
| K060994 | MONDIAL | Heraeus Kulzer, Inc. | 2006-05-22 |
Legacy Summary#
summary
FDA Review#
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