Product code EGD
- Device name
- Wax, Dental, Intraoral
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6890
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020009 | BRACE EZE | Udent, Inc. | 2002-02-11 |
| K945535 | GLENROE ORTHO-SIL | Glenroe Technologies | 1995-01-27 |
| K924024 | ORTHO WAX | Heraeus Kulzer, Inc. | 1992-11-17 |
| K923586 | BURNOUT MATERIAL | Dentsply Intl. | 1992-09-29 |
| K914892 | SALIVA-STIM | Orion Diagnostica, Inc. | 1992-09-02 |
| K922380 | BITE RIM WAX | Dentsply Intl. | 1992-06-16 |
| K914513 | PALAVIT G | Heraeus Kulzer, Inc. | 1992-03-19 |
| K910676 | INTRAORAL DENTAL WAX | Pemaco, Inc. | 1991-08-21 |
| K904928 | PALAVIT GLC | Kulzer, Inc. | 1991-06-06 |
| K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | Pemaco, Inc. | 1989-11-06 |
| K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | Pemaco, Inc. | 1989-11-06 |
| K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | Pemaco, Inc. | 1989-11-06 |
| K895563 | PEMACO BITE WAX SHEETS | Pemaco, Inc. | 1989-11-06 |
| K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | Pemaco, Inc. | 1989-11-06 |
| K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | Pemaco, Inc. | 1989-10-24 |
| K880607 | UTILITY WAX STRIPS, SPEARMINT | Columbus Dental Mfg. Co. | 1988-03-31 |
| K880606 | UTILITY WAX STRIPS, CINNAMON | Columbus Dental Mfg. Co. | 1988-03-24 |
| K863758 | ORTHO-BITE WAX WAFER | Columbus Dental Mfg. Co. | 1986-10-07 |
| K854529 | INLAY WAX REGULAR | The Hygenic Corp. | 1986-03-10 |
| K854530 | PREMIUM FLEXI-TOUGH | The Hygenic Corp. | 1986-03-04 |
| K854527 | STICKY WAX | The Hygenic Corp. | 1986-03-04 |
| K850915 | WAX BITE IMPRESSION WAFER | Toothprints, Inc. | 1985-04-16 |
| K812804 | MODERN MATERIALS' INLAY CSTG. WAXES,A-C | Modern Materials | 1982-01-26 |
| K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | Modern Materials | 1982-01-12 |
| K801911 | HOWMEDICA BITE BLOCK | Howmedica Corp. | 1980-08-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EYET6840000M0 | SOLIDUS 84 base plate wax sheet, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET68400000 | SOLIDUS 84 base plate wax sheet, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET6800000M0 | SOLIDUS 80, base plate wax sheet, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET68000000 | SOLIDUS 80, base plate wax sheet, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET6600500M0 | Sculp. Wax SUPERPINK elastic, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET66005000 | Sculp. Wax SUPERPINK elastic, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET6550500M0 | Sculp. Wax SPEZIAL winter Pink, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET65505000 | Sculp. Wax SPEZIAL winter Pink, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET6530500M0 | Sculp. Wax SPECIAL-Summer-Pink, Sample | Yeti Dentalprodukte GmbH | 2026-05-20 |
| EYET61001000 | Performed Bite rims, soft yellow “lemon” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6140490M0 | Bite wax sticks, medium, gree, “apple” ,Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61404900 | Bite wax sticks, medium, gree, “apple” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61401000 | Preformed Bite rims, very hard, pink | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET60500600 | Bite regist. Metal foil wax, brown | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6100100M0 | Performed Bite rims, soft yellow “lemon” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61101000 | Performed Bite rims, hard, pink “strawb.” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6110100M0 | Performed Bite rims, hard, pink “strawb.”,Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61204900 | Bite wax sticks, soft, yellow, “lemon” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6120490M0 | Bite wax sticks, soft, yellow, “lemon” ,Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61301000 | Performed Bite rims, medium “orange”, Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6130100M0 | Performed Bite rims, medium “orange”, Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET61304900 | Bite wax sticks, hard, pink, “strawb.” | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6130490M0 | Bite wax sticks, hard, pink, “strawb.” , Sample | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6140100M0 | Preformed Bite rims, very hard, pink | Yeti Dentalprodukte GmbH | 2026-05-11 |
| EYET6840000 | SOLIDUS 84 | Yeti Dentalprodukte GmbH | 2026-04-13 |
| 10190886135495 | NA | G & H Wire Company, Inc. | 2025-03-31 |
| 10190886135556 | NA | G & H Wire Company, Inc. | 2025-03-31 |
| 10190886106303 | N/A | G & H Wire Company, Inc. | 2023-10-09 |
| 07895742191559 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| J001702011078390 | 3M™ | 3M Deutschland GmbH | 2016-09-24 |